FDA issued a Warning Letter to Frito Lay for two allergen related issues that resulted in recalls. One occurred when at the Bakersfield, CA facility when incorrect seasoning containing undeclared milk was applied to Lay’s Barbecue Flavored Potato Chips and the other was a mislabeling issue at the Vancouver, WA facility when bags of Ruffles Cheddar & Sour Cream Potato Chip potato chips were labeled “Ruffles Original Potato Chips”. Basically, the two facilities had procedures but did not follow them.
According tot the report , the facility did not adequately implement food allergen controls at the packaging step allowing incorrect labeling where Ruffles Cheddar & Sour Cream Potato Chips were bagged as Ruffles Original bags, thus an undeclared major food allergen, milk.
In this case, the facility did not implement their roll change procedure - they were manufacturing Ruffles Cheddar & Sour Cream Potato Chips and intended to change the bagmaker to 1.5oz size Ruffles Cheddar & Sour Cream; however, the bagmaker operator incorrectly used the Ruffles Original film.
The allergen control procedure, “Film Splice Tracking,” is in place to indicate that at roll change the person will log the time, the identifying labeling film code, and attach the labeling film splice to the “Film Splice Verification” form, and then a second person will verify the labeling film code.
- These splice operations were not documented on the form.
- Also, the form indicates that the product should be identified, but on June 24, 2020, the product was not identified on this form.
- Further, the firm discontinued attaching the labeling film splice to the form in June of 2020.
Additionally, there was a procedure to verify the correct product is in the correct package and bag coding/case coding information is accurate. "The procedure also requires that the “Product” and “Flavor” be documented and that “Product Tasted / Correct Product in Bag?” is assessed and given a “GO or NO-GO.” On June 24, 2020, during the production of the recalled bags labeled “Ruffles Original Potato Chips” but containing Ruffles Cheddar & Sour Cream Potato Chips, “Product Tasted / Correct Product in Bag?” was given a “GO” even though the product documented on the form was Ruffles Cheddar & Sour Cream, and the label was “Ruffles Original.” Further wo employees signed the form, indicating that they verified the activities performed, and the discrepancy was not noted."
Allergen Cross Contact at the Bakersfield CA facility
The firm did not adequately implement the "Seasoning Allergens SSOP” and PSM (Product Safety Management) Procedure, which are allergen preventive control procedures to significantly minimize or prevent allergen cross-contact. "These procedures indicate that [the firm] will verify that all visible evidence of prior seasoning is removed [after] cleaning. On September 23, 2020, (b)(4) cleaning of packaging line (b)(4) in preparation for production of Lay’s Limón Flavored Potato Chips, orange residue, which was the same color as the seasoning used in milk-containing Ruffles Queso made immediately (b)(4) cleaning, was observed by our investigator. In particular, three orange residues approximately one millimeter in size were observed on the (b)(4) feeder (food contact surface), and two orange residues approximately one millimeter in size were observed on the interior surface of an unsealed finished product label for Lay’s Limón Flavored Potato Chips on the bagmaker of packaging Line (b)(4). These residues were observed after you conducted a (b)(4) clean-out and documented on your “(b)(4)” form that “the line has no visible evidence of previous products/seasoning run.” Further, a post-sanitation verification audit was conducted by your PSM auditor, and this area was determined to be ready for production and packaging of Lay’s Limón Flavored Potato Chips. Lay’s Limón Flavored Potato Chips do not contain milk."
FDA Warning Letter
https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/frito-lay-inc-611243-11242020
WARNING LETTER
Frito-Lay, Inc.
MARCS-CMS 611243 — November 24, 2020
FDA Warning Letter
https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/frito-lay-inc-611243-11242020
WARNING LETTER
Frito-Lay, Inc.
MARCS-CMS 611243 — November 24, 2020
Recipient:
Mr. Steven Williams
CEO
Frito-Lay, Inc.
7701 Legacy Drive
Plano, TX 75024
United States
Steven.Williams@pepsico.com
Issuing Office:
Division of Human and Animal Food Operations West III
United States
WARNING LETTER
CMS # 611243
November 24, 2020
Dear Mr. Williams:
The United States Food and Drug Administration (FDA) inspected your potato chip manufacturing facilities located at 28801 Highway 58, Bakersfield, CA from September 21 to September 25, 2020, and 4808 NW Fruit Valley Road, Vancouver, WA from September 16 to September 29, 2020. These inspections were initiated as a result of Class I recalls of your Lay’s Barbecue Flavored Potato Chips because of undeclared milk allergen due to use of an incorrect seasoning (produced at your Bakersfield, CA facility) and your bags of potato chips labeled “Ruffles Original Potato Chips” containing Ruffles Cheddar & Sour Cream Potato Chips (produced at your Vancouver, WA facility).
During our inspections of your facilities, FDA investigators found serious violations of the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food regulation (CGMP & PC rule), Title 21, Code of Federal Regulations, Part 117 (21 CFR Part 117). At the conclusion of the inspection, the FDA investigators issued each of your facilities an FDA 483 (FDA-483), Inspectional Observations. Based on FDA’s inspectional findings, we have determined that the recalled potato chips manufactured in your Bakersfield, CA facility are 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 were prepared, packed or held under insanitary conditions whereby they may have been rendered injurious to health. Further, your recalled bags of chips labeled “Ruffles Original Potato Chips” but containing Ruffles Cheddar & Sour Cream Potato Chips are misbranded within the meaning of section 403(w) of the Act [21 U.S.C. § 343(w)], in that the finished product labels did not declare a major food allergen (milk). In addition, failure of the owner, operator, or agent in charge of a covered facility to comply with the preventive controls provisions of the CGMP & PC rule (located in subparts A, C, D, E, F, and G of part 117) is prohibited by section 301(uu) of the Act (21 U.S.C. § 331(uu)). You may find the Act and further information about the CGMP & PC rule through links in FDA’s home page at http://www.fda.gov.
We received your responses to the Bakersfield, CA inspection dated October 16 and November 16, 2020 and Vancouver, WA inspection dated October 21 and November 20, 2020, which included a summary of corrective actions taken and planned by your firm. Your firm's corrective actions are discussed and delineated by location below.
Hazard Analysis and Risk-Based Preventive Controls (Subpart C):
1. You did not identify and implement preventive controls to provide assurances that any hazard requiring a preventive control will be significantly minimized or prevented and the food manufactured, processed, packed, or held by your facility will not be adulterated under section 402 or misbranded under section 403(w) of the Act, as required by 21 CFR 117.135(a)(1) and (c)(2), as evidenced by the following:
a. You did not adequately implement food allergen controls at the packaging step at your Vancouver, WA facility to significantly minimize or prevent the hazard of undeclared allergens when you packaged Ruffles Cheddar & Sour Cream Potato Chips in Ruffles Original bags on June 24, 2020. This incorrect labeling caused your product to contain an undeclared major food allergen, milk. Specifically,
• You did not implement your roll change procedure while manufacturing the recalled bags labeled “Ruffles Original Potato Chips” but containing Ruffles Cheddar & Sour Cream Potato Chips. At that time, you were manufacturing Ruffles Cheddar & Sour Cream Potato Chips and intended to change the bagmaker to 1.5oz size Ruffles Cheddar & Sour Cream; however, your bagmaker operator incorrectly used the Ruffles Original film. Your allergen control procedure, “Film Splice Tracking,” indicates that at roll change you will log the time, the identifying labeling film code, and attach the labeling film splice to the “Film Splice Verification” form, and a second person will verify the labeling film code. These splice operations were not documented on the form. Also, the form indicates that the product should be identified, but on June 24, 2020, the product was not identified on this form. Further, you discontinued attaching the labeling film splice to the form in June of 2020.
• You did not implement your procedure for “Job Aid for Package Quality & Regulatory Certification/Weaklink.” This procedure has the stated objective to "verify the correct product is in the correct package and bag coding/case coding information is accurate." The procedure also requires that the “Product” and “Flavor” be documented and that “Product Tasted / Correct Product in Bag?” is assessed and given a “GO or NO-GO.” On June 24, 2020, during the production of the recalled bags labeled “Ruffles Original Potato Chips” but containing Ruffles Cheddar & Sour Cream Potato Chips, “Product Tasted / Correct Product in Bag?” was given a “GO” even though the product documented on the form was Ruffles Cheddar & Sour Cream, and the label was “Ruffles Original.” Further, two employees signed the form, indicating that they verified the activities performed, and the discrepancy was not noted.
b. You did not adequately implement your Bakersfield, CA “(b)(4) for Seasoning Allergens SSOP” and PSM (Product Safety Management) Procedure, which are allergen preventive control procedures to significantly minimize or prevent allergen cross-contact. These procedures indicate that you will verify that all visible evidence of prior seasoning is removed (b)(4) cleaning. On September 23, 2020, (b)(4) cleaning of packaging line (b)(4) in preparation for production of Lay’s Limón Flavored Potato Chips, orange residue, which was the same color as the seasoning used in milk-containing Ruffles Queso made immediately (b)(4) cleaning, was observed by our investigator. In particular, three orange residues approximately one millimeter in size were observed on the (b)(4) feeder (food contact surface), and two orange residues approximately one millimeter in size were observed on the interior surface of an unsealed finished product label for Lay’s Limón Flavored Potato Chips on the bagmaker of packaging Line (b)(4). These residues were observed after you conducted a (b)(4) clean-out and documented on your “(b)(4)” form that “the line has no visible evidence of previous products/seasoning run.” Further, a post-sanitation verification audit was conducted by your PSM auditor, and this area was determined to be ready for production and packaging of Lay’s Limón Flavored Potato Chips. Lay’s Limón Flavored Potato Chips do not contain milk.
In your November 16 response to the Bakersfield, CA inspection and your November 20 response to the Vancouver, WA inspection, you indicate that the new seasoning application preventive control and the film splice verification preventive control should be implemented by December 31, 2020, at these facilities. The responses include updated hazard analyses, your “Seasoning Allergen” and “(b)(4) Packing Film Splice” preventive control procedures, examples of associated monitoring records, preventive control master plans, and training materials. Your October 16 and November 16 Bakersfield, CA responses include materials on the proper method of inspecting the equipment under your inspection program, updated inspectional checklists, and training records. Also, you indicate that, by January 31, 2021, you will institute the seasoning application preventive control across your entire company and the (b)(4) film splice verification preventive control across your entire company with the exception of the facilities that have deployed your “(b)(4).” Your (b)(4).” Your responses also indicate that by mid-2021 you intend to complete deployment of your “(b)(4)” across your entire company.
Class I Recalls
Your firm recalled Lay’s Barbecue Flavored Potato Chips on August 24, 2020, after receiving a consumer complaint that the chips were extremely spicy and recalled bags of chips labeled “Ruffles Original Potato Chips” but containing Ruffles Cheddar & Sour Cream Potato Chips on August 21, 2020, after receiving a consumer complaint. Your firm has had a total of five Class I recalls involving undeclared allergens in the past five years. On October 2, 2019, Frito-Lay met with the FDA to discuss the recent inspections that had occurred at Frito-Lay’s Irving, TX and Lynchburg, VA facilities. The Irving, TX facility inspection was conducted in response to the Class I recall of Lay’s Lightly Salted Barbeque Potato Chips. During the meeting, as a major part of your corrective actions to prevent future allergen issues, your firm described plans to implement technology advancements to your seasoning and packaging steps that would ensure that the correct seasoning is added to the formula and that your products are correctly labeled, preventing future allergen issues similar to those described.
Misbranding
2. Your bags labeled “Ruffles Original Potato Chips” but containing Ruffles Cheddar & Sour Cream Potato Chips, lot 34631762, are misbranded within the meaning of section 403(w) of the Act [21 U.S.C. § 343(w)], in that the finished product label fails to declare a major food allergen (milk).
Under section 201(qq) of the Act [21 U.S.C. § 321(qq)], milk is considered a “major food allergen.” A food is misbranded under section 403(w) of the Act 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 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 (e.g., “Whey (Milk)”), except 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)].
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, the CGMP & PC rule, labeling regulations, 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 the FDA without further notice, including, without limitation, seizure and injunction.
We will verify implementation of any corrective actions during FDA’s next inspection of your facility. If you would like to provide further details pertaining to the corrective actions taken by your firm and provide documentation, including revised procedures and completed monitoring records that would assist us in evaluating your corrections, please notify this office in writing within fifteen (15) working days of the receipt of this letter.
If you believe that your products are not in violation of the Act or that you have complied with FDA regulations, include your reasoning and any supporting information for our consideration. If the corrective action cannot be completed within fifteen working days, state the reason for the delay and the time frame within which the corrections will be implemented.
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 re-inspection related costs. A re-inspection 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. Re-inspection related costs means all expenses, including administrative expenses, incurred in connection with FDA’s arranging, conducting, and evaluating the results of the re-inspection and assessing and collecting the re-inspection fees [21 U.S.C. 379j-31(a)(2)(B)]. For a domestic facility, FDA will assess and collect fees for re-inspection related costs from the responsible party for the domestic facility. The inspection noted in this letter identified non-compliance materially related to a food safety requirement of the Act. Accordingly, FDA may assess fees to cover any re-inspection-related costs.
Please send your reply to the Food and Drug Administration Dallas District Office, Attention: Rian L. Pope, Compliance Officer, 1201 Main Street, Suite 7200, Dallas, TX 75202. If you have questions regarding any issues cited in this letter, please contact Mr. Pope at 210-308-1415 or at Rian.Pope@fda.hhs.gov.
Sincerely,
/S/
Edmundo Garcia Jr.
District Director | FDA Dallas District
Program Division Director
Office of Human and Animal Foods
Operations – West Division 3
cc: Lori Woznicki, Food and Drug Inspections Branch
Manager, Division of Regulatory Services
Texas Department of State Health Services
lori.woznicki@dshs.texas.gov
Mr. Steven Williams
CEO
Frito-Lay, Inc.
7701 Legacy Drive
Plano, TX 75024
United States
Steven.Williams@pepsico.com
Issuing Office:
Division of Human and Animal Food Operations West III
United States
WARNING LETTER
CMS # 611243
November 24, 2020
Dear Mr. Williams:
The United States Food and Drug Administration (FDA) inspected your potato chip manufacturing facilities located at 28801 Highway 58, Bakersfield, CA from September 21 to September 25, 2020, and 4808 NW Fruit Valley Road, Vancouver, WA from September 16 to September 29, 2020. These inspections were initiated as a result of Class I recalls of your Lay’s Barbecue Flavored Potato Chips because of undeclared milk allergen due to use of an incorrect seasoning (produced at your Bakersfield, CA facility) and your bags of potato chips labeled “Ruffles Original Potato Chips” containing Ruffles Cheddar & Sour Cream Potato Chips (produced at your Vancouver, WA facility).
During our inspections of your facilities, FDA investigators found serious violations of the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food regulation (CGMP & PC rule), Title 21, Code of Federal Regulations, Part 117 (21 CFR Part 117). At the conclusion of the inspection, the FDA investigators issued each of your facilities an FDA 483 (FDA-483), Inspectional Observations. Based on FDA’s inspectional findings, we have determined that the recalled potato chips manufactured in your Bakersfield, CA facility are 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 were prepared, packed or held under insanitary conditions whereby they may have been rendered injurious to health. Further, your recalled bags of chips labeled “Ruffles Original Potato Chips” but containing Ruffles Cheddar & Sour Cream Potato Chips are misbranded within the meaning of section 403(w) of the Act [21 U.S.C. § 343(w)], in that the finished product labels did not declare a major food allergen (milk). In addition, failure of the owner, operator, or agent in charge of a covered facility to comply with the preventive controls provisions of the CGMP & PC rule (located in subparts A, C, D, E, F, and G of part 117) is prohibited by section 301(uu) of the Act (21 U.S.C. § 331(uu)). You may find the Act and further information about the CGMP & PC rule through links in FDA’s home page at http://www.fda.gov.
We received your responses to the Bakersfield, CA inspection dated October 16 and November 16, 2020 and Vancouver, WA inspection dated October 21 and November 20, 2020, which included a summary of corrective actions taken and planned by your firm. Your firm's corrective actions are discussed and delineated by location below.
Hazard Analysis and Risk-Based Preventive Controls (Subpart C):
1. You did not identify and implement preventive controls to provide assurances that any hazard requiring a preventive control will be significantly minimized or prevented and the food manufactured, processed, packed, or held by your facility will not be adulterated under section 402 or misbranded under section 403(w) of the Act, as required by 21 CFR 117.135(a)(1) and (c)(2), as evidenced by the following:
a. You did not adequately implement food allergen controls at the packaging step at your Vancouver, WA facility to significantly minimize or prevent the hazard of undeclared allergens when you packaged Ruffles Cheddar & Sour Cream Potato Chips in Ruffles Original bags on June 24, 2020. This incorrect labeling caused your product to contain an undeclared major food allergen, milk. Specifically,
• You did not implement your roll change procedure while manufacturing the recalled bags labeled “Ruffles Original Potato Chips” but containing Ruffles Cheddar & Sour Cream Potato Chips. At that time, you were manufacturing Ruffles Cheddar & Sour Cream Potato Chips and intended to change the bagmaker to 1.5oz size Ruffles Cheddar & Sour Cream; however, your bagmaker operator incorrectly used the Ruffles Original film. Your allergen control procedure, “Film Splice Tracking,” indicates that at roll change you will log the time, the identifying labeling film code, and attach the labeling film splice to the “Film Splice Verification” form, and a second person will verify the labeling film code. These splice operations were not documented on the form. Also, the form indicates that the product should be identified, but on June 24, 2020, the product was not identified on this form. Further, you discontinued attaching the labeling film splice to the form in June of 2020.
• You did not implement your procedure for “Job Aid for Package Quality & Regulatory Certification/Weaklink.” This procedure has the stated objective to "verify the correct product is in the correct package and bag coding/case coding information is accurate." The procedure also requires that the “Product” and “Flavor” be documented and that “Product Tasted / Correct Product in Bag?” is assessed and given a “GO or NO-GO.” On June 24, 2020, during the production of the recalled bags labeled “Ruffles Original Potato Chips” but containing Ruffles Cheddar & Sour Cream Potato Chips, “Product Tasted / Correct Product in Bag?” was given a “GO” even though the product documented on the form was Ruffles Cheddar & Sour Cream, and the label was “Ruffles Original.” Further, two employees signed the form, indicating that they verified the activities performed, and the discrepancy was not noted.
b. You did not adequately implement your Bakersfield, CA “(b)(4) for Seasoning Allergens SSOP” and PSM (Product Safety Management) Procedure, which are allergen preventive control procedures to significantly minimize or prevent allergen cross-contact. These procedures indicate that you will verify that all visible evidence of prior seasoning is removed (b)(4) cleaning. On September 23, 2020, (b)(4) cleaning of packaging line (b)(4) in preparation for production of Lay’s Limón Flavored Potato Chips, orange residue, which was the same color as the seasoning used in milk-containing Ruffles Queso made immediately (b)(4) cleaning, was observed by our investigator. In particular, three orange residues approximately one millimeter in size were observed on the (b)(4) feeder (food contact surface), and two orange residues approximately one millimeter in size were observed on the interior surface of an unsealed finished product label for Lay’s Limón Flavored Potato Chips on the bagmaker of packaging Line (b)(4). These residues were observed after you conducted a (b)(4) clean-out and documented on your “(b)(4)” form that “the line has no visible evidence of previous products/seasoning run.” Further, a post-sanitation verification audit was conducted by your PSM auditor, and this area was determined to be ready for production and packaging of Lay’s Limón Flavored Potato Chips. Lay’s Limón Flavored Potato Chips do not contain milk.
In your November 16 response to the Bakersfield, CA inspection and your November 20 response to the Vancouver, WA inspection, you indicate that the new seasoning application preventive control and the film splice verification preventive control should be implemented by December 31, 2020, at these facilities. The responses include updated hazard analyses, your “Seasoning Allergen” and “(b)(4) Packing Film Splice” preventive control procedures, examples of associated monitoring records, preventive control master plans, and training materials. Your October 16 and November 16 Bakersfield, CA responses include materials on the proper method of inspecting the equipment under your inspection program, updated inspectional checklists, and training records. Also, you indicate that, by January 31, 2021, you will institute the seasoning application preventive control across your entire company and the (b)(4) film splice verification preventive control across your entire company with the exception of the facilities that have deployed your “(b)(4).” Your (b)(4).” Your responses also indicate that by mid-2021 you intend to complete deployment of your “(b)(4)” across your entire company.
Class I Recalls
Your firm recalled Lay’s Barbecue Flavored Potato Chips on August 24, 2020, after receiving a consumer complaint that the chips were extremely spicy and recalled bags of chips labeled “Ruffles Original Potato Chips” but containing Ruffles Cheddar & Sour Cream Potato Chips on August 21, 2020, after receiving a consumer complaint. Your firm has had a total of five Class I recalls involving undeclared allergens in the past five years. On October 2, 2019, Frito-Lay met with the FDA to discuss the recent inspections that had occurred at Frito-Lay’s Irving, TX and Lynchburg, VA facilities. The Irving, TX facility inspection was conducted in response to the Class I recall of Lay’s Lightly Salted Barbeque Potato Chips. During the meeting, as a major part of your corrective actions to prevent future allergen issues, your firm described plans to implement technology advancements to your seasoning and packaging steps that would ensure that the correct seasoning is added to the formula and that your products are correctly labeled, preventing future allergen issues similar to those described.
Misbranding
2. Your bags labeled “Ruffles Original Potato Chips” but containing Ruffles Cheddar & Sour Cream Potato Chips, lot 34631762, are misbranded within the meaning of section 403(w) of the Act [21 U.S.C. § 343(w)], in that the finished product label fails to declare a major food allergen (milk).
Under section 201(qq) of the Act [21 U.S.C. § 321(qq)], milk is considered a “major food allergen.” A food is misbranded under section 403(w) of the Act 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 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 (e.g., “Whey (Milk)”), except 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)].
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, the CGMP & PC rule, labeling regulations, 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 the FDA without further notice, including, without limitation, seizure and injunction.
We will verify implementation of any corrective actions during FDA’s next inspection of your facility. If you would like to provide further details pertaining to the corrective actions taken by your firm and provide documentation, including revised procedures and completed monitoring records that would assist us in evaluating your corrections, please notify this office in writing within fifteen (15) working days of the receipt of this letter.
If you believe that your products are not in violation of the Act or that you have complied with FDA regulations, include your reasoning and any supporting information for our consideration. If the corrective action cannot be completed within fifteen working days, state the reason for the delay and the time frame within which the corrections will be implemented.
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 re-inspection related costs. A re-inspection 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. Re-inspection related costs means all expenses, including administrative expenses, incurred in connection with FDA’s arranging, conducting, and evaluating the results of the re-inspection and assessing and collecting the re-inspection fees [21 U.S.C. 379j-31(a)(2)(B)]. For a domestic facility, FDA will assess and collect fees for re-inspection related costs from the responsible party for the domestic facility. The inspection noted in this letter identified non-compliance materially related to a food safety requirement of the Act. Accordingly, FDA may assess fees to cover any re-inspection-related costs.
Please send your reply to the Food and Drug Administration Dallas District Office, Attention: Rian L. Pope, Compliance Officer, 1201 Main Street, Suite 7200, Dallas, TX 75202. If you have questions regarding any issues cited in this letter, please contact Mr. Pope at 210-308-1415 or at Rian.Pope@fda.hhs.gov.
Sincerely,
/S/
Edmundo Garcia Jr.
District Director | FDA Dallas District
Program Division Director
Office of Human and Animal Foods
Operations – West Division 3
cc: Lori Woznicki, Food and Drug Inspections Branch
Manager, Division of Regulatory Services
Texas Department of State Health Services
lori.woznicki@dshs.texas.gov
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