Home Life Health Food Two New York food firms put on notice about import violations
0

Two New York food firms put on notice about import violations

0
   

Two New York food firms put on notice about import violations

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.


Eli’s Manhattan Warehouse Inc.
New York, NY

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

In a Dec. 14, 2021, warning letter, the FDA described an Aug. 23 through Sept. 7, 2021, Foreign Supplier Verification Program (FSVP) inspection of Eli’s Manhattan Warehouse Inc. in New York, NY.

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 significant violations are as follows:

The firm did not develop, maintain, and follow an FSVP. Specifically, they did not develop an FSVP for each of the following foods:

  • Blueberry, strawberry, cherry jams from (redacted) located in (redacted)
  • Olive oil from (redacted) located in (redacted)
  • Honey from (redacted) located in (redacted)

The full warning letter can be viewed here.

Agroson’s LLC
Bronx, NY

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

In a March 11, 2022, warning letter, the FDA described an Aug. 20 through Sept. 3, 2021, Foreign Supplier Verification Program (FSVP) inspection of Agroson’s LLC in Bronx, NY.

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 significant violations are as follows:

  1. The firm did not develop, maintain, and follow an FSVP. Specifically, they did not develop an FSVP for each of the following foods:
  • Limes imported from (redacted)
  • Limes imported from (redacted)
  1. The firm must conduct a hazard analysis for each type of food they import to determine whether there are any hazards requiring a control. Although they may meet this requirement by reviewing and assessing the hazard analysis conducted by another entity using a qualified individual, the firm must document their review and assessment of the hazard analysis, including documenting that the hazard analysis was conducted by a qualified individual. During FDA  inspection they provided a hazard analysis for papaya which they obtained from (redacted) and a document that they identified to be the hazard analysis for papaya that they obtained from (redacted). However, the firm did not provide documentation that they have reviewed and assessed their foreign supplier’s hazard analysis as required.
  2. The firm must approve their foreign suppliers on the basis of an evaluation of their foreign supplier’s performance and the risk posed by the food for the foods they import. The firm must consider the hazard analysis of the food, the entity or entities that would be significantly minimizing or preventing the hazards requiring a control or verifying that such hazards have been significantly minimized or prevented, the foreign supplier performance, and any other factors as appropriate and necessary. However, in the firm’s Foreign Supplier Verification Form for their foreign supplier (redacted):

   The firm stated they reviewed the supplier’s relevant food safety records. However, they did not document their review in accordance with regulations. Such documentation may include identifying what specific relevant food safety records were reviewed, who reviewed the records, and the date the records were reviewed.

   The firm identified the applicable food safety regulation in their second Question 10 of their FSV Form, which states, “List FDA regulation that the Foreign Supplier is subject to in relation to food safety.” However, they have not identified what steps they took to verify that the foreign suppliers are complying with that regulation. Question 12 on the same form states, “List the applicable Foreign Supplier Evaluation Procedure.” The firm states that they review food safety manuals and sample analysis reports and verify both past food safety violations and (redacted). However, they have not identified how they verify past food safety violations.

  • The firm provided a document in a foreign language that they identified to be the foreign supplier evaluation for their foreign supplier of papaya, (redacted). The firm may meet the requirements of 21 CFR 1.505 by complying with section 1.505(d) and reviewing and assessing another entity’s evaluation of their foreign supplier’s performance and risk posed by the food. However, the FDA is unable to determine whether the firm reviewed and assessed this document, in part because they did not provide an English translation of the foreign supplier evaluation.
  1. The firm did not meet the requirement to perform foreign supplier verification activities. Specifically, they did not establish written procedures for ensuring that appropriate supplier verification activities are conducted in accordance with regulation, and they did not document their determination of the appropriate supplier verification activity or activities, or the frequency with which the activity or activities must be conducted.
  2. The firm must make all records required under this subpart available promptly to an authorized FDA representative, upon request, for inspection and copying. Upon FDA request, the firm must provide within a reasonable time an English translation of records maintained in a language other than English. However, they did not provide an English translation of the following FSVP documents after the investigator’s request of the referenced documents in English: hazard analysis, foreign supplier evaluation documentation, and verification documentation for (redacted); and the hazard analysis, a portion of the foreign supplier evaluation documentation (pages 1-3, 7-9, & 12-19 of the document “(redacted) FSVP” that they provided FDA investigators), and a portion of the verification documentation for (redacted). To date, they have still not provided the requested translation of these documents.

The full warning letter can be viewed here.

(To sign up for a free subscription to Food Safety News, click here)

 
   

Follow us on Instagram

This error message is only visible to WordPress admins

Error: No connected account.

Please go to the Instagram Feed settings page to connect an account.