As part of its enforcement activities, the Food and Drug Administration sends warning letters to entities under its jurisdiction. Some letters are not posted for public view until weeks or months after they are sent. Business owners have 15 days to respond to FDA warning letters. Warning letters often are not issued until a company has been given months to years to correct problems. The FDA frequently redacts parts of warning letters posted for public view.

NEM Advisors LLC/Shop & Save Market
Niles, IL

An import company in Illinois is on notice from the FDA for not having FSVPs for a number of imported food products.

In an April 15 warning letter, the FDA described a Jan. 21-26, 2020, remote Foreign Supplier Verification Program (FSVP) inspection for NEM Advisors LLC/Shop & Save Market. The FDA’s inspection revealed that the firm was not in compliance with FSVP regulations and resulted in the issuance of an FDA Form 483a.

The firm’s significant violations of the FSVP regulation are as follows:

The firm did not develop, maintain, and follow an FSVP. Specifically, the firm did not develop an FSVP for any of the foods they import, including but not limited to, the following foods:

  • Bread Mix imported from (redacted), located in (redacted).
  • Dough Bread Mix imported from (redacted), located in (redacted).
  • Farmer’s Cheese imported from (redacted), located in (redacted).

The full warning letter can be viewed here.

George DeLallo Company, Inc.
Mount Pleasant, PA

A food firm in Pennsylvania is on notice from the FDA for misbranding violations. Mislabeling and undeclared allergens can be a serious threat to public health, according to U.S. regulations.

In a March 30 warning letter, the FDA determined that George DeLallo Company’s recalled Holiday Cookie Platter and Provolini Antipasti products manufactured at your Mount Pleasant, PA, were misbranded, in that the finished product labels did not declare the major food allergens pecans and milk, respectively.

On Dec. 5, 2020, the firm recalled their Holiday Cookie Platter product after notification from a customer that it was mislabeled. Their 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 Dec. 5, 2020, the firm indicated that a supervisor placed the wrong roll of labels on a labeling machine and that the incorrect bottom label with the ingredients statement was used. On Jan. 5, 2021, the firm provided the Division Recall Coordinator with a description of their 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.

On Nov. 24, 2020, the firm recalled their Provolini Antipasti product labeled as Garlic Mushrooms after notification by a customer that it was mislabeled. The 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 Dec. 1, 2020, the firm indicated that a line worker placed the wrong label on one side of the labeling machine. On Dec. 15, 2020, the firm provided the Division Recall Coordinator with a description of their 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 being used that day and will organize them on a cart outside 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).

The FDA will verify the implementation of any corrective actions during the FDA’s next inspection of their facility.

The full warning letter can be viewed here.

Hanover Foods Corp.
Hanover, PA

A food firm in Pennsylvania is on notice from the FDA for misbranding violations. Mislabeling and undeclared allergens can be a serious threat to public health, according to U.S. regulations.

In a March 26 warning letter, the FDA said Hanover Foods Corporation’s recalled Baked Rice Pudding and Cheddar Flavored Popcorn incorrectly labeled as Butter Flavored Popcorn was misbranded in that the finished product labels did not declare the major food allergens milk and egg in the pudding, and milk in the popcorn.

On Oct. 9, 2020, after being notified by a customer of the mislabeled product, the firm recalled Baked Rice Pudding that was labeled with the ingredient list for Red Chicken Chili with Beans. The firm’s 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, the firm indicated that an unknown malfunction in the label printing software caused three consecutive production runs of Rice Pudding to be mislabeled.

On Dec. 21, 2020, the firm provided a description of their corrective actions to the Division Recall Coordinator. The firm stated that the root cause of the problem was a duplicate database in the firm’s labeling software that was subsequently deleted. After the deletion, they stated that they audited every label for compliance. In addition, they now require label room personnel to provide labels from each day’s production to the Quality Assurance department, where they will be verified against the firm’s written allergen labeling procedure. The firm stated that their written allergen labeling procedures have been updated, and they provided an example of an allergen labeling monitoring record for FDA review.

 The FDA will verify the implementation of any corrective actions during the FDA’s next inspection of their facility.

On Jan. 25, 2021, after being notified by a retail employee of the mislabeled product, the firm recalled Cheddar Flavored Popcorn incorrectly labeled as Butter Flavored Popcorn. Their 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 Feb. 16, 2021, the firm 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 their, “HACCP Plan will be reassessed to include label review/allergen check as a CCP.”

The FDA will verify the implementation of any corrective actions during the FDA’s next inspection of their facility.

The full warning letter can be viewed here.

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