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.
City of Industry, CA
An import company in California is on notice from the FDA for not having FSVPs for a number of imported food products. In a Nov. 24 warning letter, the FDA described a July 20-29, 2020, remote Foreign Supplier Verification Program (FSVP) inspection for Mexi-Land Inc.
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’s significant violations of the FSVP regulation are as follows:
- 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, they must document their review and assessment of that hazard analysis, including documenting that the hazard analysis was conducted by a qualified individual. During the inspection, the firm provided copies of their (redacted) food safety plan for soft candy tamarind flavor, (redacted) HACCP plan for chocolate covered marshmallow lollipops, and their foreign supplier (redacted) HACCP plan for Enchilokas mango soft candy. However, for each of these, they did not provide documentation that they have reviewed and assessed their foreign supplier’s hazard analysis.
- The firm did not approve their foreign suppliers on the basis of an evaluation of the foreign supplier’s performance and the risk posed by the food and document their approval. For example, for their foreign suppliers (redacted) they did not evaluate their foreign supplier’s performance and the risk posed by the food, approve their foreign supplier on the basis of this evaluation and document their approval.
- The firm did not establish and follow written procedures to ensure that they import foods only from foreign suppliers they have approved based on an evaluation of the foreign supplier’s performance and the risk posed by the food and document their use of these procedures.
- The firm did not meet the requirement to, before importing a food from a foreign supplier, determine and document which verification activity or activities, as well as the frequency with which the activity or activities must be conducted, are needed to provide adequate assurances that the food they obtain from the foreign supplier is produced in accordance with regulation.
- The firm did not meet the requirement to conduct and document (or obtain documentation of) one or more of the supplier verification activities for each foreign supplier before importing the food and periodically thereafter. For example, they did not conduct and document (or obtain documentation of) one or more such supplier verification activities for their foreign supplier (redacted) before importing soft candy tamarind flavor and periodically thereafter or for their foreign supplier (redacted) before importing chocolate covered marshmallow lollipops and periodically thereafter. Furthermore, while they obtained a Certificate of Analysis for Enchilokas mango soft candy imported from (redacted), which reported physicochemical and microbiological analysis for lot 7213, they did not document their review and assessment of these results.
The full warning letter can be viewed here.
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