One recall occurred when Baked Rice Pudding was labeled with the ingredient list for Red Chicken Chili with Beans. The problem was a "duplicate database in your labeling software that was subsequently deleted".
The second recall which occurred at another subsidiary was for Cheddar Flavored Popcorn incorrectly labeled as Butter Flavored Popcorn. The Cheddar Flavored Popcorn contains milk but the ingredient list for Butter Flavored Popcorn did not declare this allergen. The firm "indicated that the error occurred when bags containing Cheddar Flavored Popcorn were inadvertently labeled as Butter Flavored Popcorn."
The important takeaway from this is that FDA is taking a stand for allergen labeling and is elevating its response when the same firm has multiple issues, even if those issues are in different operations/divisions.
https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/hanover-foods-corporation-612551-03262021
Hanover Foods Corporation
MARCS-CMS 612551 — MARCH 26, 2021
Recipient:
Jeffrey Warehime
CEO
Hanover Foods Corporation
1486 York Street
Hanover, PA 17331
United States
Issuing Office:
Division of Human and Animal Food Operations East II
United States
March 26, 2021
WARNING LETTER
CMS #612551
Dear Mr. Warehime:
The United States Food and Drug Administration (FDA) has determined that your recalled Baked Rice Pudding manufactured at your subsidiary, Spring Glen Fresh Foods in Ephrata, Pennsylvania, and Cheddar Flavored Popcorn incorrectly labeled as Butter Flavored Popcorn manufactured at your subsidiary, Bickel’s Snack Foods Inc. in York, Pennsylvania are misbranded within the meaning of section 403(w) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 343(w)], in that the finished product labels did not declare the major food allergens milk and egg (pudding) and milk (popcorn). The introduction or delivery for introduction into interstate commerce of any food that is misbranded is prohibited by section 301(a) of the Act [21 U.S.C. § 331(a)]. You may find the Act and further information about relevant requirements through links on the FDA website at www.fda.gov.External Link Disclaimer
On October 9, 2020, after being notified by a customer of the mislabeled product, your firm recalled Baked Rice Pudding that was labeled with the ingredient list for Red Chicken Chili with Beans. Your Baked Rice Pudding contains milk and egg, but the ingredient list for Red Chicken Chili with Beans did not declare these allergens. In email documentation provided to the Office of Human and Animal Food Operations Division 2 East Recall Coordinator, including product information, product labeling, recall details, and attachment B information, you indicated that an unknown malfunction in the label printing software caused three consecutive production runs of Rice Pudding to be mislabeled.
On December 21, 2020, you provided a description of your corrective actions to the Division Recall Coordinator. You stated that the root cause of the problem was a duplicate database in your labeling software that was subsequently deleted. After the deletion, you stated that you audited every label for compliance. In addition, you now require label room personnel to provide labels from each day’s production to the Quality Assurance department, where they will be verified against your written allergen labeling procedure. You stated that your written allergen labeling procedures have been updated, and you provided an example of an allergen labeling monitoring record for FDA review. We will verify implementation of any corrective actions during FDA’s next inspection of your facility.
On January 25, 2021, after being notified by a retail employee of the mislabeled product, your firm recalled Cheddar Flavored Popcorn incorrectly labeled as Butter Flavored Popcorn. Your Cheddar Flavored Popcorn contains milk but the ingredient list for Butter Flavored Popcorn did not declare this allergen. In email documentation provided to the Office of Human and Animal Food Operations Division 2 East Recall Coordinator on February 16, 2021, you indicated that the error occurred when bags containing Cheddar Flavored Popcorn were inadvertently labeled as Butter Flavored Popcorn. Further, this documentation states that as a corrective action your, “HACCP Plan will be reassessed to include label review/allergen check as a CCP.” We will verify implementation of any corrective actions during FDA’s next inspection of your facility.
Misbranding
Your recalled Rice Pudding and Cheddar Flavored Popcorn 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 of milk and egg (Rice Pudding) and milk (Cheddar Flavored Popcorn) as required by section 403(w)(1) of the Act. Specifically, your Rice Pudding was manufactured with milk and egg, but the labeled ingredients do not list milk and egg because the ingredient statement on the label was for a different product that does not contain milk or egg. Further, your Cheddar Flavored Popcorn is manufactured with ingredients that contain milk, but the labeled ingredients do not list milk because the ingredient statement on the label was for a different product that does not contain milk.
Section 201(qq) of the Act [21 U.S.C. § 321(qq)], defines 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 the exception of highly refined oils as “major food allergens.” 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:
Additional comments
Your facilities are subject to the requirements of the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food regulation (CGMP and PC rule) (21 CFR Part 117). As such, you are required to identify and implement preventive controls to provide assurances that any hazard requiring a preventive control (e.g., undeclared allergens) will be significantly minimized or prevented and the food manufactured, processed, packed, or held by your facilities will not be adulterated under section 402 or misbranded under section 403(w) of the Act (21 CFR 117.135(a)(1) and (c)(2)). The 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 (subparts A, C, D, E, F, and G) is prohibited by section 301(uu) of the Act [21 U.S.C. § 331(uu)].
The violations cited in this letter are not intended to be an all-inclusive statement of violations that exist in connection with your marketed products. You are responsible for investigating and determining the causes of any violations and for preventing their recurrence or the occurrence of other violations. It is your responsibility to ensure that your firm complies with all requirements of federal law, including FDA regulations.
You should take prompt action to address the violations cited in this letter. Failure to promptly address these violations may result in legal action without further notice including, without limitation, seizure and injunction. Please notify FDA in writing, within 15 working days of receipt of this letter, of the specific steps you have taken to address these violations. Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. If you believe that your products are not in violation of the FD&C Act, include your reasoning and any supporting information for our consideration. If you cannot complete addressing these violations within 15 working days, state the reason for the delay and the time within which you will do so.
Your written response should be sent to the attention of Jessica D. Weber, Compliance Officer at U.S. Food and Drug Administration, 6000 Metro Drive, Suite 101, Baltimore, Maryland 21215. An emailed response is also acceptable. Files greater than 100 megabytes may be submitted as smaller files in separate emails. If you have questions regarding this letter, please contact CO Weber by telephone at 410-779-5407, or by email at jessica.weber@fda.hhs.gov.
Sincerely,
/S/
Randy F. Pack
District Director/Program Division Director
Baltimore District Office
Human & Animal Food East, Division 2
Office of Regulatory Affairs
U.S. Food and Drug Administration
Jeffrey Warehime
CEO
Hanover Foods Corporation
1486 York Street
Hanover, PA 17331
United States
Issuing Office:
Division of Human and Animal Food Operations East II
United States
March 26, 2021
WARNING LETTER
CMS #612551
Dear Mr. Warehime:
The United States Food and Drug Administration (FDA) has determined that your recalled Baked Rice Pudding manufactured at your subsidiary, Spring Glen Fresh Foods in Ephrata, Pennsylvania, and Cheddar Flavored Popcorn incorrectly labeled as Butter Flavored Popcorn manufactured at your subsidiary, Bickel’s Snack Foods Inc. in York, Pennsylvania are misbranded within the meaning of section 403(w) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 343(w)], in that the finished product labels did not declare the major food allergens milk and egg (pudding) and milk (popcorn). The introduction or delivery for introduction into interstate commerce of any food that is misbranded is prohibited by section 301(a) of the Act [21 U.S.C. § 331(a)]. You may find the Act and further information about relevant requirements through links on the FDA website at www.fda.gov.External Link Disclaimer
On October 9, 2020, after being notified by a customer of the mislabeled product, your firm recalled Baked Rice Pudding that was labeled with the ingredient list for Red Chicken Chili with Beans. Your Baked Rice Pudding contains milk and egg, but the ingredient list for Red Chicken Chili with Beans did not declare these allergens. In email documentation provided to the Office of Human and Animal Food Operations Division 2 East Recall Coordinator, including product information, product labeling, recall details, and attachment B information, you indicated that an unknown malfunction in the label printing software caused three consecutive production runs of Rice Pudding to be mislabeled.
On December 21, 2020, you provided a description of your corrective actions to the Division Recall Coordinator. You stated that the root cause of the problem was a duplicate database in your labeling software that was subsequently deleted. After the deletion, you stated that you audited every label for compliance. In addition, you now require label room personnel to provide labels from each day’s production to the Quality Assurance department, where they will be verified against your written allergen labeling procedure. You stated that your written allergen labeling procedures have been updated, and you provided an example of an allergen labeling monitoring record for FDA review. We will verify implementation of any corrective actions during FDA’s next inspection of your facility.
On January 25, 2021, after being notified by a retail employee of the mislabeled product, your firm recalled Cheddar Flavored Popcorn incorrectly labeled as Butter Flavored Popcorn. Your Cheddar Flavored Popcorn contains milk but the ingredient list for Butter Flavored Popcorn did not declare this allergen. In email documentation provided to the Office of Human and Animal Food Operations Division 2 East Recall Coordinator on February 16, 2021, you indicated that the error occurred when bags containing Cheddar Flavored Popcorn were inadvertently labeled as Butter Flavored Popcorn. Further, this documentation states that as a corrective action your, “HACCP Plan will be reassessed to include label review/allergen check as a CCP.” We will verify implementation of any corrective actions during FDA’s next inspection of your facility.
Misbranding
Your recalled Rice Pudding and Cheddar Flavored Popcorn 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 of milk and egg (Rice Pudding) and milk (Cheddar Flavored Popcorn) as required by section 403(w)(1) of the Act. Specifically, your Rice Pudding was manufactured with milk and egg, but the labeled ingredients do not list milk and egg because the ingredient statement on the label was for a different product that does not contain milk or egg. Further, your Cheddar Flavored Popcorn is manufactured with ingredients that contain milk, but the labeled ingredients do not list milk because the ingredient statement on the label was for a different product that does not contain milk.
Section 201(qq) of the Act [21 U.S.C. § 321(qq)], defines 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 the exception of highly refined oils as “major food allergens.” 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)].
Additional comments
Your facilities are subject to the requirements of the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food regulation (CGMP and PC rule) (21 CFR Part 117). As such, you are required to identify and implement preventive controls to provide assurances that any hazard requiring a preventive control (e.g., undeclared allergens) will be significantly minimized or prevented and the food manufactured, processed, packed, or held by your facilities will not be adulterated under section 402 or misbranded under section 403(w) of the Act (21 CFR 117.135(a)(1) and (c)(2)). The 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 (subparts A, C, D, E, F, and G) is prohibited by section 301(uu) of the Act [21 U.S.C. § 331(uu)].
The violations cited in this letter are not intended to be an all-inclusive statement of violations that exist in connection with your marketed products. You are responsible for investigating and determining the causes of any violations and for preventing their recurrence or the occurrence of other violations. It is your responsibility to ensure that your firm complies with all requirements of federal law, including FDA regulations.
You should take prompt action to address the violations cited in this letter. Failure to promptly address these violations may result in legal action without further notice including, without limitation, seizure and injunction. Please notify FDA in writing, within 15 working days of receipt of this letter, of the specific steps you have taken to address these violations. Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. If you believe that your products are not in violation of the FD&C Act, include your reasoning and any supporting information for our consideration. If you cannot complete addressing these violations within 15 working days, state the reason for the delay and the time within which you will do so.
Your written response should be sent to the attention of Jessica D. Weber, Compliance Officer at U.S. Food and Drug Administration, 6000 Metro Drive, Suite 101, Baltimore, Maryland 21215. An emailed response is also acceptable. Files greater than 100 megabytes may be submitted as smaller files in separate emails. If you have questions regarding this letter, please contact CO Weber by telephone at 410-779-5407, or by email at jessica.weber@fda.hhs.gov.
Sincerely,
/S/
Randy F. Pack
District Director/Program Division Director
Baltimore District Office
Human & Animal Food East, Division 2
Office of Regulatory Affairs
U.S. Food and Drug Administration
No comments:
Post a Comment