- No allergen control
- Poor cleaning - residual raw dough present after cleaning (and we all know this creates a Salmonella / E. coli growth opportunity).
- Leaky roofs - source of Salmonella and moisture
- Poor pest control - presence of insects, poor protection against entry
- Poor personal hygiene practices - people not wearing hair protection
- Improper labeling
- Improper labeling
With FSMA, bakeries may be getting more attention than in the past. Because products are generally considered low risk, they have not received the scrutiny of higher risk products. However, with issues from allergens to Salmonella in flour/dough, they are not risk free.
Nobel Bakery, Inc. 3/16/17
Nobel Bakery, Inc. 3/16/17
https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2017/ucm549608.htm
WARNING LETTER
March 16, 2017
WL# 19-17
Norik Nikogosyan, President/Co-Owner
Nobel Bakery, Inc.
5638 Cahuenga Blvd.
North Hollywood, CA 91601-2103
Dear Mr. Nikogosyan:
The United States Food and Drug Administration (FDA) inspected your ready-to-eat manufacturing facility located at 5638 Cahuenga Blvd., North Hollywood, California, from October 3 through October 13, 2016. During the inspection, FDA investigators observed serious violations of the Current Good Manufacturing Practice (CGMP) regulation for foods, Title 21, Code of Federal Regulations (CFR), Part 110 [21 CFR Part 110].[1] At the conclusion of the inspection, you were issued a Form FDA-483, Inspectional Observations, which documented insanitary conditions in your facility at the time of the inspection. Failure to manufacture foods in accordance with the CGMP requirements in 21 CFR Part 110 renders your firm's food products adulterated within the meaning of Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 342(a)(4)], in that they have been prepared, packed, or held under insanitary conditions whereby they may have become contaminated with filth, or whereby they may have been rendered injurious to heath.
Additionally, during the inspection our investigators obtained the labels that your firm uses for your various ready-to-eat bakery products. We have reviewed your labels and identified violations of the food labeling regulations, 21 CFR Part 101, which causes the products discussed below to be misbranded within the meaning of Section 403 of the Act [21 U.S.C. § 343].
Further, your “Apricot Perouk,” “Croissant with Jam,” and “French Cookies” products are adulterated within the meaning of section 402(c) of the Act because they contain a color additive which is unsafe within the meaning of section 721(a) of the Act.
You may find the Act and FDA’s regulations through links in FDA’s home page at www.fda.gov.
Your significant violations are as follows:
Foods Adulterated under Section 402(a)(4) of the Act:
1.) You must perform filling, assembling, packaging, and other operations in such a manner that protects food from becoming contaminated, as required by 21 CFR 110.80(b)(13). However, you have no allergen control program in place, such as scheduling production based on allergens, having dedicated equipment, or cleaning between your products, although some of your products contain tree nuts, milk, eggs, wheat, and soy.
2.) You must maintain buildings, fixtures, and other physical facilities in a sanitary condition and keep in sufficient repair to prevent food from becoming adulterated within the meaning of the Act, as required by 21 CFR 110.35(a). However, on October 3 and 6, 2016, our investigator observed the ceiling inside the (b)(4) storage area had visible water damage. Although you replastered the area, you stated that when it rains, water leaks from this area.
3.) You must ensure seams on food-contact surfaces are smoothly bonded or maintained to minimize accumulation of food particles, dirt, and organic matter, as required by 21 CFR 110.40(b). However, on October 3 and 6, 2016, our investigators observed food accumulating in deep gaps in your (b)(4) tables. Raw dough was still visible after post-production cleaning.
4.) You must store raw materials in a manner that protects against contamination and minimizes deterioration, as required by 21 CFR 110.80(a)(1). However, on October 3, 2016 our investigators observed a (b)(4) bowl containing chocolate, stored uncovered in a refrigerator, underneath the cooling system that had unknown white particles. Some of these particles were observed to have landed on the chocolate.
This is a repeat violation from FDA’s May 2011 inspection, as containers of raw ingredients were also observed uncovered during these inspections.
5.) You must take effective measures to exclude pests from the processing areas and protect against the contamination of food on the premises by pests, as required by 21 CFR 110.35(c). However, on October 3, 2016, our investigators observed the following:
a) At least four flies inside the (b)(4) room where raw uncovered dough was being handled and directly on the (b)(4) tables after post-production cleaning was completed. Additionally, on October 6, 2016, four flies were observed in the facility, including directly on finished product Puff Pastry in the (b)(4) room and on dough scraps in the raw production room.
b) One spider on the floor by the west wall of the (b)(4) storage area.
c) One unidentified dead insect on the north wall of the (b)(4) storage area.
Furthermore, there were no visual indicators that you are using a pest control program, such as bait stations, fly traps, etc. When our investigator asked for records of visits from a pest control company, you were unable to provide any documentation.
6.) You must provide adequate screening or other protection against pests, as required by 21 CFR 110.20(b)(7). However, on October 3, 2016, our investigators observed the following repeat violations from FDA’s May 2011 inspection:
a) Upon initial arrival at the firm, all three doors leading into the building were wide open with no protective screening; specifically a door leading into the (b)(4) room while a rack of finished product was at the doorway, and two doors at opposite ends of the (b)(4) room where raw dough was being handled.
b) The front screen door leading to the (b)(4) room had an approximate ½ inch gap across the top, an approximate 2 inch x 1½ inch gap on the lower left corner, and an approximate ¼ inch high gap on the bottom.
c) The front screen door leading to the (b)(4) had an approximate ½ inch gap on the right edge, and at least 2 inch x 1 inch gaps on both bottom corners.
7.) You must provide safety-type lighting fixtures over exposed food, as required by 21 CFR 110.20(b)(5). However, our investigators observed two fluorescent light tubes without safety coverings over areas where raw uncovered product is handled.
We acknowledge that during the inspection you promised to purchase covers for the lights. However, this same violation was observed during FDA’s May 2011 inspection, and at that time you promised to make corrections.
8.) You must provide food handlers and supervisors appropriate training in proper food handling techniques and food-protection principles and they should be informed of the danger of poor personal hygiene and insanitary practices, as required by 21 CFR 110.10(c). However, based on our investigator’s observations of employee practices, it appears employees have not been provided appropriate training as evidenced by the following:
a) As the President/Co-Owner of the company, you did not wear any protective hair covering while accompanying our investigator through the walk-through of the facility, while production and packaging activities were taking place.
b) At least six employees without any hair coverings were working directly with raw dough in the raw production room. Another employee with a significant amount of hair sticking out of their hair net was packaging finished product Walnut Nazook.
c) An employee packaging finished product Puff Pastry with bare hands while wearing an ornate ring.
d) Various employees wearing jewelry, such as a bracelet, watch, earrings, necklace, and a pair of headphones while packing finished product Walnut Nazook and Puff Pastry. This is a repeat violation from FDA’s May 2011 inspection.
e) A personal water bottle was located on a shelf underneath a (b)(4) table in the raw production room, and another water bottle was located on the three compartment sink shelf located next to cake pans.
f) A purse and a cell phone were located on a shelf underneath a table where finished product Puff Pastry and Walnut Nazook were being packaged. This is a repeat violation from FDA’s May 2011 inspection.
Additionally, your firm does not have a formal training program; you rely on senior employees to train newer employees.
Foods Adulterated under Section 402(c) of the Act:
Your “Apricot Perouk,” “Croissant with Jam,” and “French Cookies” products are adulterated within the meaning of section 402(c) of the Act [21 U.S.C. 342(c)] because they contain a color additive which is unsafe within the meaning of section 721(a) of the Act [21 USC 379e(a)]. Specifically, the (b)(4) filling used in these products contains the food color FD&C Yellow No. 5. FD&C Yellow No. 5 is specifically required to be declared on food product labels under 21 CFR 74.705(d)(2); however, the color is not declared on the product labels of these products.
Misbranded Foods:
1) Your “Apricot Perouk,” “Walnut Nazook,” “Orange Cake,” “French Cookies,” “Zaban,” “Puff Pastry,” and “Nazook” products are misbranded within the meaning of section 403(a)(1) of the Act [21 U.S.C. § 343(a)(1)] in that the labeling is false or misleading. Specifically:
a) The “Apricot Perouk,” “Walnut Nazook,” “Orange Cake,” and “French Cookies” finished product labels bear the claim "No Preservatives." However, some ingredients used in these products, such as (b)(4), (b)(4), and (b)(4) contain preservatives including, but not limited to, (b)(4), and (b)(4), according to their labels. Thus, your “No Preservatives” statement on your finished product labels is false and misleading.
b) The “Zaban,” “Walnut Nazook,” “Puff Pastry,” and “Nazook” labels are misleading because two different ingredient lists are displayed and visible on the finished product label. As a result, it is unclear which ingredient list, if either, is associated with the product at issue. Correcting label mistakes in any manner, including by using a sticker label, is acceptable if the final label is correct and complies with all regulations at the time of retail sale. The stickers should not cover other mandatory labeling, and should adhere tightly.
2) Your “Low Sugar Nazook” product is misbranded within the meaning of section 403(r)(1)(A) of the Act [21 U.S.C. § 343(r)(1)(A)] because the labeling for the product bears a nutrient content claim that is not authorized by regulation. Under section 403(r)(2)(A)(i) of the Act, a claim that characterizes the level of a nutrient which is of the type required to be in the labeling of the food must be made in accordance with a regulation authorizing the use of such a claim. The use of a term not defined by regulation in food labeling to characterize the level of a nutrient misbrands the product under section 403(r)(1)(A) of the Act.
While FDA has defined some nutrient content claims for sugar in 21 CFR 101.60(c), FDA has not defined "low sugar"; therefore, the use of this claim misbrands your product under section 403(r)(1)(A) of the Act. Furthermore, even if “low sugar” is considered to be synonymous with the claim “lower sugar,” your use of the claim does not conform with the applicable FDA regulation. The claim "lower sugar" may be used on the label or labeling of foods provided that it meets the requirements of 21 CFR 101.60(c)(5). 21 CFR 101.60(c)(5) requires, in part, that the claim declares the identity of an appropriate reference food and the percent (or fraction) that the sugar differs between the two foods. The claim on your "Low Sugar Nazook" product labeling does not meet these requirements.
3) Several of your products, including but not limited to, “Apricot Perouk,” “Walnut Nazook,” “Croissant with Jam,” “Low Sugar Nazook,” and “Orange Cake” products are misbranded within the meaning of section 403(w) of the Act [21 U.S.C. § 343(w)] in that the finished product labels fail to declare the major food allergens present in the products as required by section 403(w)(1) of the Act.
Section 201(qq) of the Act, 21 U.S.C. § 321(qq), defines a major food allergen as milk, egg, fish, Crustacean shellfish, tree nuts, wheat, peanuts, and soybeans, as well as any food ingredient that contains protein derived from one of these foods, with certain exceptions, e.g., highly refined oils derived from a major food allergen. A food is misbranded if it is not a raw agricultural commodity and it is, or it contains, an ingredient that bears or contains, a major food allergen, unless either:
The word “Contains,” followed by the name of the food source from which the major food allergen is derived, is printed immediately after or is adjacent to the list of ingredients [section 403(w)(1)(A) of the Act, 21 U.S.C. § 343(w)(1)(A)], or
The common or usual name of the major food allergen in the list of ingredients is followed in parentheses by the name of the food source from which the major food allergen is derived, except that the name of the food source is not required when either the common or usual name of the ingredient uses the name of the food source or the name of the food source appears elsewhere in the ingredient list (unless the name of the food source that appears elsewhere in the ingredient list appears as part of the name of an ingredient that is not a major food allergen) [section 403(w)(1)(B) of the Act, 21 U.S.C. § 343(w)(1)(B)].
Specifically:
a) Your “Apricot Perouk,” “Croissant with Jam,” “Low Sugar Nazook,” and “Orange Cake” products are manufactured using (b)(4), which contains the allergen wheat, but wheat is not declared on your finished product labels.
b) Your “Apricot Perouk” product is manufactured using (b)(4), which contains the allergen milk, but milk is not declared on your finished product label.
c) Your “Walnut Nazook” product is manufactured using (b)(4), which is not listed on your finished product labels or on the supplemental ingredient sticker that you provided during the inspection for “Walnut Nazook.” The (b)(4) ingredient used contains the allergen soy.
4) Your “Apricot Perouk,” “Croissant with Jam,” “French Cookies,” and “Orange Cake” products are misbranded under section 403(k) of the Act [21 U.S.C. 343(k)] because the products contain an artificial coloring, flavoring, or a chemical preservative and fail to bear labeling stating that fact. Specifically, FD&C Yellow No. 5 and FD&C Yellow No. 6, which are ingredients in the (b)(4) filling used in the “Apricot Perouk,” “Croissant with Jam,” and “French Cookies” products, are not declared by their listed names or appropriate abbreviations in accordance with 21 CFR 101.22(k)(1).
5) Your product "Low Sugar Nazook" is misbranded within the meaning of section 403(q) of the Act [21 U.S.C. § 343(q)] in that the label fails to bear nutrition information (e.g. Nutrition Facts Panel), as required by 21 CFR 101.9 and 21 CFR 101.13(n).
6) Your “French Cookies,” “Walnut Nazook,” “Low Sugar Nazook,” “Croissant with Jam,” “Orange Cake,” and “Apricot Perouk” products are misbranded within meaning of section 403(i)(2) of the Act [21 U.S.C. § 343(i)(2)] in that they are fabricated from two or more ingredients and each ingredient is not declared on the labels, as required by 21 CFR 101.4(a).
Further, your labels must list the sub-ingredients of any ingredient that is a multi-component ingredient, including, but not limited to, (b)(4), (b)(4), (b)(4), and (b)(4) in accordance with 21 CFR 101.4(b)(2). The requirement to list these component ingredients (or “sub-ingredients”) may be met by either parenthetically listing the component ingredients after the common or usual name of the main ingredient, or by listing the component ingredients without listing the ingredient itself. Under the first alternative, the component ingredients must be listed in descending order of predominance within the multi-component ingredient; and under the second alternative, the component ingredients must be listed in descending order of predominance in the finished food.
For example:
a) Your product “French Cookies” consists of an assortment of cookies that includes cookies with the ingredient “(b)(4).” The cookie assortment was also observed to include cookies with a (b)(4) topping and cookies with a (b)(4) topping that resembles (b)(4). However, these (b)(4), (b)(4), and (b)(4) filling ingredients are not declared on either your original finished product label or on the supplemental ingredient sticker that you provided during the inspection (21 CFR 101.4(a)).
b) Your “Walnut Nazook” finished product label fails to list the (b)(4) ingredient used in the product (21 CFR 101.4(a)).
c) Your “Low Sugar Nazook” and “Croissant with Jam” finished product labels fail to list the (b)(4) ingredient used in the products. Additionally, the labels list (b)(4), but according to information provided during the inspection, it is not an ingredient in the products (21 CFR 101.4(a)).
d) Your “Orange Cake” finished product label fails to declare that a flavor ingredient is used (21 CFR 101.4(a)(1) and (b)(1), 21 CFR 101.22(h)(1)).
e) Your “Apricot Perouk” and “Croissant with Jam” labels do not declare the sub-ingredients of the (b)(4) filling used in the products (21 CFR 101.4(b)).
f) Your “Walnut Nazook,” “Orange Cake,” “Croissant with Jam,” and “French Cookies” finished product labels list the ingredient “(b)(4)” but fail to list the (b)(4) sub-ingredients (21 CFR 101.4(b)).
7) Your “Croissant with Jam” product is misbranded under section 403(i)(1) of the Act [21 U.S.C. 343(i)(1)] because the use of the term, “jam,” in the name of the product is not appropriate. According to the information you provided during the inspection, it is manufactured using “(b)(4).” “(b)(4),” or “(b)(4),” as declared on the label, is not an appropriate common or usual name for the (b)(4) filling ingredient. The standards for fruit preserves, jams, and jellies are provided for in 21 CFR 150.160, and do not provide for the use of artificial color. The (b)(4) filling used contains the artificial food colors FD&C Yellow No. 5 and FD&C Yellow No. 6.
This letter is not intended to be an all-inclusive list of violations at your facility or in connection with your products. You are responsible for ensuring that your facility operates in compliance with the Act and other applicable laws.
You should take prompt action to correct the violations noted in this letter. Failure to do so may result in regulatory action by FDA without further notice, including, without limitation, seizure and injunction.
We also offer the following labeling comment:
We note that your “Apricot Perouk” finished product label lists the ingredient “(b)(4).” According to the information provided during the inspection, the ingredient you use in the product is “(b)(4).” We question whether “(b)(4)” is an appropriate common or usual name for the apricot filling ingredient. Please see the guidance at the following link for additional information: http://www.fda.gov/ICECI/ComplianceManuals/CompliancePolicyGuidanceManual/ucm074536.htm.
You should respond in writing within 15 working days of receipt of this letter describing the specific steps you have taken to correct the noted violations and to prevent these violations or other similar violations from occurring again. In your response, you should include documentation, including photographs, corrective actions you have taken to date, or other useful information that would assist us in evaluating your corrections. If you cannot complete all corrections before you respond, you should state the reason for the delay and include a timetable for implementation of those corrections.
Section 743 of the Act (21 U.S.C. 379j-31) authorizes FDA to assess and collect fees to cover FDA’s costs for certain activities, including reinspection-related costs. A reinspection is one or more inspections conducted subsequent to an inspection that identified noncompliance materially related to a food safety requirement of the Act, specifically to determine whether compliance has been achieved. Reinspection-related costs means all expenses, including administrative expenses, incurred in connection with FDA’s arranging, conducting, and evaluating the results of the reinspection and assessing and collecting the reinspection fees (21 U.S.C. 379j-31(a)(2)(B)). For a domestic facility, FDA will assess and collect fees for reinspection-related costs from the responsible party for the domestic facility. The inspection noted in this letter identified noncompliance materially related to a food safety requirement of the Act. Accordingly, FDA may assess fees to cover any reinspection-related costs.
Your written response should be directed to:
Kelly Sheppard
Director, Compliance Branch
Food & Drug Administration
Los Angeles District Office
19701 Fairchild
Irvine, CA 92612
Refer to the Unique Identification Number (CMS #511044) when replying.
If you have questions regarding this letter, please contact Rochelle A. Rolnik, Compliance Officer at rochelle.rolnik@fda.hhs.gov, or (949) 608-4496.
Sincerely,
/S/
CDR Steven E. Porter, Jr.
Director, Los Angeles District
Los Angeles District
19701 Fairchild, Irvine CA 92612-2506
Telephone: 949-608-2900
Fax: 949-608-4417
cc: David Mazerra, Ph.D.
Chief, Food and Drug Branch
California Department of Public Health
1500 Capitol Avenue - MS 7602
P.O. Box 997413
Sacramento, California 95899-7435
[1] Part 110 was modernized and codified in Subpart B of Part 117 by the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food rule (21 CFR Part 117) (PC rule). An establishment will continue to be subject to Part 110 until the Part 117 compliance date applicable to its business size. See http://www.fda.gov/Food/GuidanceRegulation/FSMA/ucm334115.htm#Compliance_Dates for PC rule compliance dates.
WARNING LETTER
March 16, 2017
WL# 19-17
Norik Nikogosyan, President/Co-Owner
Nobel Bakery, Inc.
5638 Cahuenga Blvd.
North Hollywood, CA 91601-2103
Dear Mr. Nikogosyan:
The United States Food and Drug Administration (FDA) inspected your ready-to-eat manufacturing facility located at 5638 Cahuenga Blvd., North Hollywood, California, from October 3 through October 13, 2016. During the inspection, FDA investigators observed serious violations of the Current Good Manufacturing Practice (CGMP) regulation for foods, Title 21, Code of Federal Regulations (CFR), Part 110 [21 CFR Part 110].[1] At the conclusion of the inspection, you were issued a Form FDA-483, Inspectional Observations, which documented insanitary conditions in your facility at the time of the inspection. Failure to manufacture foods in accordance with the CGMP requirements in 21 CFR Part 110 renders your firm's food products adulterated within the meaning of Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 342(a)(4)], in that they have been prepared, packed, or held under insanitary conditions whereby they may have become contaminated with filth, or whereby they may have been rendered injurious to heath.
Additionally, during the inspection our investigators obtained the labels that your firm uses for your various ready-to-eat bakery products. We have reviewed your labels and identified violations of the food labeling regulations, 21 CFR Part 101, which causes the products discussed below to be misbranded within the meaning of Section 403 of the Act [21 U.S.C. § 343].
Further, your “Apricot Perouk,” “Croissant with Jam,” and “French Cookies” products are adulterated within the meaning of section 402(c) of the Act because they contain a color additive which is unsafe within the meaning of section 721(a) of the Act.
You may find the Act and FDA’s regulations through links in FDA’s home page at www.fda.gov.
Your significant violations are as follows:
Foods Adulterated under Section 402(a)(4) of the Act:
1.) You must perform filling, assembling, packaging, and other operations in such a manner that protects food from becoming contaminated, as required by 21 CFR 110.80(b)(13). However, you have no allergen control program in place, such as scheduling production based on allergens, having dedicated equipment, or cleaning between your products, although some of your products contain tree nuts, milk, eggs, wheat, and soy.
2.) You must maintain buildings, fixtures, and other physical facilities in a sanitary condition and keep in sufficient repair to prevent food from becoming adulterated within the meaning of the Act, as required by 21 CFR 110.35(a). However, on October 3 and 6, 2016, our investigator observed the ceiling inside the (b)(4) storage area had visible water damage. Although you replastered the area, you stated that when it rains, water leaks from this area.
3.) You must ensure seams on food-contact surfaces are smoothly bonded or maintained to minimize accumulation of food particles, dirt, and organic matter, as required by 21 CFR 110.40(b). However, on October 3 and 6, 2016, our investigators observed food accumulating in deep gaps in your (b)(4) tables. Raw dough was still visible after post-production cleaning.
4.) You must store raw materials in a manner that protects against contamination and minimizes deterioration, as required by 21 CFR 110.80(a)(1). However, on October 3, 2016 our investigators observed a (b)(4) bowl containing chocolate, stored uncovered in a refrigerator, underneath the cooling system that had unknown white particles. Some of these particles were observed to have landed on the chocolate.
This is a repeat violation from FDA’s May 2011 inspection, as containers of raw ingredients were also observed uncovered during these inspections.
5.) You must take effective measures to exclude pests from the processing areas and protect against the contamination of food on the premises by pests, as required by 21 CFR 110.35(c). However, on October 3, 2016, our investigators observed the following:
a) At least four flies inside the (b)(4) room where raw uncovered dough was being handled and directly on the (b)(4) tables after post-production cleaning was completed. Additionally, on October 6, 2016, four flies were observed in the facility, including directly on finished product Puff Pastry in the (b)(4) room and on dough scraps in the raw production room.
b) One spider on the floor by the west wall of the (b)(4) storage area.
c) One unidentified dead insect on the north wall of the (b)(4) storage area.
Furthermore, there were no visual indicators that you are using a pest control program, such as bait stations, fly traps, etc. When our investigator asked for records of visits from a pest control company, you were unable to provide any documentation.
6.) You must provide adequate screening or other protection against pests, as required by 21 CFR 110.20(b)(7). However, on October 3, 2016, our investigators observed the following repeat violations from FDA’s May 2011 inspection:
a) Upon initial arrival at the firm, all three doors leading into the building were wide open with no protective screening; specifically a door leading into the (b)(4) room while a rack of finished product was at the doorway, and two doors at opposite ends of the (b)(4) room where raw dough was being handled.
b) The front screen door leading to the (b)(4) room had an approximate ½ inch gap across the top, an approximate 2 inch x 1½ inch gap on the lower left corner, and an approximate ¼ inch high gap on the bottom.
c) The front screen door leading to the (b)(4) had an approximate ½ inch gap on the right edge, and at least 2 inch x 1 inch gaps on both bottom corners.
7.) You must provide safety-type lighting fixtures over exposed food, as required by 21 CFR 110.20(b)(5). However, our investigators observed two fluorescent light tubes without safety coverings over areas where raw uncovered product is handled.
We acknowledge that during the inspection you promised to purchase covers for the lights. However, this same violation was observed during FDA’s May 2011 inspection, and at that time you promised to make corrections.
8.) You must provide food handlers and supervisors appropriate training in proper food handling techniques and food-protection principles and they should be informed of the danger of poor personal hygiene and insanitary practices, as required by 21 CFR 110.10(c). However, based on our investigator’s observations of employee practices, it appears employees have not been provided appropriate training as evidenced by the following:
a) As the President/Co-Owner of the company, you did not wear any protective hair covering while accompanying our investigator through the walk-through of the facility, while production and packaging activities were taking place.
b) At least six employees without any hair coverings were working directly with raw dough in the raw production room. Another employee with a significant amount of hair sticking out of their hair net was packaging finished product Walnut Nazook.
c) An employee packaging finished product Puff Pastry with bare hands while wearing an ornate ring.
d) Various employees wearing jewelry, such as a bracelet, watch, earrings, necklace, and a pair of headphones while packing finished product Walnut Nazook and Puff Pastry. This is a repeat violation from FDA’s May 2011 inspection.
e) A personal water bottle was located on a shelf underneath a (b)(4) table in the raw production room, and another water bottle was located on the three compartment sink shelf located next to cake pans.
f) A purse and a cell phone were located on a shelf underneath a table where finished product Puff Pastry and Walnut Nazook were being packaged. This is a repeat violation from FDA’s May 2011 inspection.
Additionally, your firm does not have a formal training program; you rely on senior employees to train newer employees.
Foods Adulterated under Section 402(c) of the Act:
Your “Apricot Perouk,” “Croissant with Jam,” and “French Cookies” products are adulterated within the meaning of section 402(c) of the Act [21 U.S.C. 342(c)] because they contain a color additive which is unsafe within the meaning of section 721(a) of the Act [21 USC 379e(a)]. Specifically, the (b)(4) filling used in these products contains the food color FD&C Yellow No. 5. FD&C Yellow No. 5 is specifically required to be declared on food product labels under 21 CFR 74.705(d)(2); however, the color is not declared on the product labels of these products.
Misbranded Foods:
1) Your “Apricot Perouk,” “Walnut Nazook,” “Orange Cake,” “French Cookies,” “Zaban,” “Puff Pastry,” and “Nazook” products are misbranded within the meaning of section 403(a)(1) of the Act [21 U.S.C. § 343(a)(1)] in that the labeling is false or misleading. Specifically:
a) The “Apricot Perouk,” “Walnut Nazook,” “Orange Cake,” and “French Cookies” finished product labels bear the claim "No Preservatives." However, some ingredients used in these products, such as (b)(4), (b)(4), and (b)(4) contain preservatives including, but not limited to, (b)(4), and (b)(4), according to their labels. Thus, your “No Preservatives” statement on your finished product labels is false and misleading.
b) The “Zaban,” “Walnut Nazook,” “Puff Pastry,” and “Nazook” labels are misleading because two different ingredient lists are displayed and visible on the finished product label. As a result, it is unclear which ingredient list, if either, is associated with the product at issue. Correcting label mistakes in any manner, including by using a sticker label, is acceptable if the final label is correct and complies with all regulations at the time of retail sale. The stickers should not cover other mandatory labeling, and should adhere tightly.
2) Your “Low Sugar Nazook” product is misbranded within the meaning of section 403(r)(1)(A) of the Act [21 U.S.C. § 343(r)(1)(A)] because the labeling for the product bears a nutrient content claim that is not authorized by regulation. Under section 403(r)(2)(A)(i) of the Act, a claim that characterizes the level of a nutrient which is of the type required to be in the labeling of the food must be made in accordance with a regulation authorizing the use of such a claim. The use of a term not defined by regulation in food labeling to characterize the level of a nutrient misbrands the product under section 403(r)(1)(A) of the Act.
While FDA has defined some nutrient content claims for sugar in 21 CFR 101.60(c), FDA has not defined "low sugar"; therefore, the use of this claim misbrands your product under section 403(r)(1)(A) of the Act. Furthermore, even if “low sugar” is considered to be synonymous with the claim “lower sugar,” your use of the claim does not conform with the applicable FDA regulation. The claim "lower sugar" may be used on the label or labeling of foods provided that it meets the requirements of 21 CFR 101.60(c)(5). 21 CFR 101.60(c)(5) requires, in part, that the claim declares the identity of an appropriate reference food and the percent (or fraction) that the sugar differs between the two foods. The claim on your "Low Sugar Nazook" product labeling does not meet these requirements.
3) Several of your products, including but not limited to, “Apricot Perouk,” “Walnut Nazook,” “Croissant with Jam,” “Low Sugar Nazook,” and “Orange Cake” products are misbranded within the meaning of section 403(w) of the Act [21 U.S.C. § 343(w)] in that the finished product labels fail to declare the major food allergens present in the products as required by section 403(w)(1) of the Act.
Section 201(qq) of the Act, 21 U.S.C. § 321(qq), defines a major food allergen as milk, egg, fish, Crustacean shellfish, tree nuts, wheat, peanuts, and soybeans, as well as any food ingredient that contains protein derived from one of these foods, with certain exceptions, e.g., highly refined oils derived from a major food allergen. A food is misbranded if it is not a raw agricultural commodity and it is, or it contains, an ingredient that bears or contains, a major food allergen, unless either:
The word “Contains,” followed by the name of the food source from which the major food allergen is derived, is printed immediately after or is adjacent to the list of ingredients [section 403(w)(1)(A) of the Act, 21 U.S.C. § 343(w)(1)(A)], or
The common or usual name of the major food allergen in the list of ingredients is followed in parentheses by the name of the food source from which the major food allergen is derived, except that the name of the food source is not required when either the common or usual name of the ingredient uses the name of the food source or the name of the food source appears elsewhere in the ingredient list (unless the name of the food source that appears elsewhere in the ingredient list appears as part of the name of an ingredient that is not a major food allergen) [section 403(w)(1)(B) of the Act, 21 U.S.C. § 343(w)(1)(B)].
Specifically:
a) Your “Apricot Perouk,” “Croissant with Jam,” “Low Sugar Nazook,” and “Orange Cake” products are manufactured using (b)(4), which contains the allergen wheat, but wheat is not declared on your finished product labels.
b) Your “Apricot Perouk” product is manufactured using (b)(4), which contains the allergen milk, but milk is not declared on your finished product label.
c) Your “Walnut Nazook” product is manufactured using (b)(4), which is not listed on your finished product labels or on the supplemental ingredient sticker that you provided during the inspection for “Walnut Nazook.” The (b)(4) ingredient used contains the allergen soy.
4) Your “Apricot Perouk,” “Croissant with Jam,” “French Cookies,” and “Orange Cake” products are misbranded under section 403(k) of the Act [21 U.S.C. 343(k)] because the products contain an artificial coloring, flavoring, or a chemical preservative and fail to bear labeling stating that fact. Specifically, FD&C Yellow No. 5 and FD&C Yellow No. 6, which are ingredients in the (b)(4) filling used in the “Apricot Perouk,” “Croissant with Jam,” and “French Cookies” products, are not declared by their listed names or appropriate abbreviations in accordance with 21 CFR 101.22(k)(1).
5) Your product "Low Sugar Nazook" is misbranded within the meaning of section 403(q) of the Act [21 U.S.C. § 343(q)] in that the label fails to bear nutrition information (e.g. Nutrition Facts Panel), as required by 21 CFR 101.9 and 21 CFR 101.13(n).
6) Your “French Cookies,” “Walnut Nazook,” “Low Sugar Nazook,” “Croissant with Jam,” “Orange Cake,” and “Apricot Perouk” products are misbranded within meaning of section 403(i)(2) of the Act [21 U.S.C. § 343(i)(2)] in that they are fabricated from two or more ingredients and each ingredient is not declared on the labels, as required by 21 CFR 101.4(a).
Further, your labels must list the sub-ingredients of any ingredient that is a multi-component ingredient, including, but not limited to, (b)(4), (b)(4), (b)(4), and (b)(4) in accordance with 21 CFR 101.4(b)(2). The requirement to list these component ingredients (or “sub-ingredients”) may be met by either parenthetically listing the component ingredients after the common or usual name of the main ingredient, or by listing the component ingredients without listing the ingredient itself. Under the first alternative, the component ingredients must be listed in descending order of predominance within the multi-component ingredient; and under the second alternative, the component ingredients must be listed in descending order of predominance in the finished food.
For example:
a) Your product “French Cookies” consists of an assortment of cookies that includes cookies with the ingredient “(b)(4).” The cookie assortment was also observed to include cookies with a (b)(4) topping and cookies with a (b)(4) topping that resembles (b)(4). However, these (b)(4), (b)(4), and (b)(4) filling ingredients are not declared on either your original finished product label or on the supplemental ingredient sticker that you provided during the inspection (21 CFR 101.4(a)).
b) Your “Walnut Nazook” finished product label fails to list the (b)(4) ingredient used in the product (21 CFR 101.4(a)).
c) Your “Low Sugar Nazook” and “Croissant with Jam” finished product labels fail to list the (b)(4) ingredient used in the products. Additionally, the labels list (b)(4), but according to information provided during the inspection, it is not an ingredient in the products (21 CFR 101.4(a)).
d) Your “Orange Cake” finished product label fails to declare that a flavor ingredient is used (21 CFR 101.4(a)(1) and (b)(1), 21 CFR 101.22(h)(1)).
e) Your “Apricot Perouk” and “Croissant with Jam” labels do not declare the sub-ingredients of the (b)(4) filling used in the products (21 CFR 101.4(b)).
f) Your “Walnut Nazook,” “Orange Cake,” “Croissant with Jam,” and “French Cookies” finished product labels list the ingredient “(b)(4)” but fail to list the (b)(4) sub-ingredients (21 CFR 101.4(b)).
7) Your “Croissant with Jam” product is misbranded under section 403(i)(1) of the Act [21 U.S.C. 343(i)(1)] because the use of the term, “jam,” in the name of the product is not appropriate. According to the information you provided during the inspection, it is manufactured using “(b)(4).” “(b)(4),” or “(b)(4),” as declared on the label, is not an appropriate common or usual name for the (b)(4) filling ingredient. The standards for fruit preserves, jams, and jellies are provided for in 21 CFR 150.160, and do not provide for the use of artificial color. The (b)(4) filling used contains the artificial food colors FD&C Yellow No. 5 and FD&C Yellow No. 6.
This letter is not intended to be an all-inclusive list of violations at your facility or in connection with your products. You are responsible for ensuring that your facility operates in compliance with the Act and other applicable laws.
You should take prompt action to correct the violations noted in this letter. Failure to do so may result in regulatory action by FDA without further notice, including, without limitation, seizure and injunction.
We also offer the following labeling comment:
We note that your “Apricot Perouk” finished product label lists the ingredient “(b)(4).” According to the information provided during the inspection, the ingredient you use in the product is “(b)(4).” We question whether “(b)(4)” is an appropriate common or usual name for the apricot filling ingredient. Please see the guidance at the following link for additional information: http://www.fda.gov/ICECI/ComplianceManuals/CompliancePolicyGuidanceManual/ucm074536.htm.
You should respond in writing within 15 working days of receipt of this letter describing the specific steps you have taken to correct the noted violations and to prevent these violations or other similar violations from occurring again. In your response, you should include documentation, including photographs, corrective actions you have taken to date, or other useful information that would assist us in evaluating your corrections. If you cannot complete all corrections before you respond, you should state the reason for the delay and include a timetable for implementation of those corrections.
Section 743 of the Act (21 U.S.C. 379j-31) authorizes FDA to assess and collect fees to cover FDA’s costs for certain activities, including reinspection-related costs. A reinspection is one or more inspections conducted subsequent to an inspection that identified noncompliance materially related to a food safety requirement of the Act, specifically to determine whether compliance has been achieved. Reinspection-related costs means all expenses, including administrative expenses, incurred in connection with FDA’s arranging, conducting, and evaluating the results of the reinspection and assessing and collecting the reinspection fees (21 U.S.C. 379j-31(a)(2)(B)). For a domestic facility, FDA will assess and collect fees for reinspection-related costs from the responsible party for the domestic facility. The inspection noted in this letter identified noncompliance materially related to a food safety requirement of the Act. Accordingly, FDA may assess fees to cover any reinspection-related costs.
Your written response should be directed to:
Kelly Sheppard
Director, Compliance Branch
Food & Drug Administration
Los Angeles District Office
19701 Fairchild
Irvine, CA 92612
Refer to the Unique Identification Number (CMS #511044) when replying.
If you have questions regarding this letter, please contact Rochelle A. Rolnik, Compliance Officer at rochelle.rolnik@fda.hhs.gov, or (949) 608-4496.
Sincerely,
/S/
CDR Steven E. Porter, Jr.
Director, Los Angeles District
Los Angeles District
19701 Fairchild, Irvine CA 92612-2506
Telephone: 949-608-2900
Fax: 949-608-4417
cc: David Mazerra, Ph.D.
Chief, Food and Drug Branch
California Department of Public Health
1500 Capitol Avenue - MS 7602
P.O. Box 997413
Sacramento, California 95899-7435
[1] Part 110 was modernized and codified in Subpart B of Part 117 by the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food rule (21 CFR Part 117) (PC rule). An establishment will continue to be subject to Part 110 until the Part 117 compliance date applicable to its business size. See http://www.fda.gov/Food/GuidanceRegulation/FSMA/ucm334115.htm#Compliance_Dates for PC rule compliance dates.
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