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  5. George DeLallo Company, Inc. - 612553 - 03/30/2021
  1. Warning Letters

WARNING LETTER

George DeLallo Company, Inc. MARCS-CMS 612553 —

Delivery Method:
VIA UPS
Product:
Food & Beverages
Recipient:
Recipient Name
Mr. Francis X. DeLallo
Recipient Title
President
George DeLallo Company, Inc.

1 DeLallo Way
Mount Pleasant, PA 15666
United States

Issuing Office:
Division of Human and Animal Food Operations East II

United States

March 30, 2021

WARNING LETTER

CMS #612553

Dear Mr. DeLallo:

The United States Food and Drug Administration (FDA) has determined that your recalled Holiday Cookie Platter and Provolini Antipasti products manufactured at your Mount Pleasant, Pennsylvania facility located at 1 DeLallo Way, Mount Pleasant, PA 15666 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 pecans and milk, respectively.

On December 5, 2020, you recalled your Holiday Cookie Platter product after notification from a customer that it was mislabeled. Your recalled Holiday Cookie Platter product contains pecans that were not declared on the label. In documentation provided to the Office of Human and Animal Food Operations Division 2 East Recall Coordinator on December 5, 2020, you indicated that a supervisor placed the wrong roll of labels on the labeling machine and that the incorrect bottom label with the ingredients statement was used. On January 5, 2021, you provided the Division Recall Coordinator with a description of your corrective actions that included the following:
• Label selection is now done on the previous day, with all labels selected by Quality Control personnel.
• Labels are provided to the Production Supervisor by the Quality Control Manager.
• If additional labels are needed to complete production, the Production Supervisor will notify QC, and the labels will be selected by QC and verified.
• During production all labels are verified.

We will verify implementation of any corrective actions during FDA’s next inspection of your facility.

On November 24, 2020, you recalled your Provolini Antipasti product labeled as Garlic Mushrooms after notification by a customer that it was mislabeled. Your recalled Provolini Antipasti contains milk, but the label for Garlic Mushrooms that was applied to the bag does not declare milk. In documentation provided to the Division Recall Coordinator on December 1, 2020, you indicated that a line worker placed the wrong label on one side of the labeling machine. On December 15, 2020, you provided the Division Recall Coordinator with a description of your corrective actions that included the following:
• Select all labels for Operations prior to production startup. The Quality Manager or properly trained designee will locate the proper labels to being used that day and will organize them on a cart out-side the label storage area.
• All Food Safety and Quality Assurance activities will fall under the responsibility of Quality Assurance (not Quality Assurance/Production hybrid role).

We will verify implementation of any corrective actions during FDA’s next inspection of your facility.

Misbranding

Your recalled Holiday Cookie Platter and Provolini Antipasti 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 pecans and milk, respectively.

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 un-der 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 else-where 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 manufacturing facility is subject to the requirements of the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food regulation (21 CFR Part 117) (CGMP and PC rule). 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 facility 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 the recurrence or 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 addresses 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 that you have taken to address these violations. Include an explanation of each step being taken to pre-vent the recurrence of violations, as well as copies of related documentation. If you believe that your products are not in violation of the 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 frame 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 410-608-8403, 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 Division II East
Office of Regulatory Affairs
U.S. Food and Drug Administration

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