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.

McElroy Imports
Glen Mills, PA

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

In a May 12 warning letter, the FDA described a Jan. 27 through Feb. 9. 2021, remote Foreign Supplier Verification Program (FSVP) inspection of McElroy Imports in Glen Mills, PA.

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 FDA acknowledged the firm’s response email dated Feb. 9, 2021. The firm stated that they would “advise (redacted) of (the FDA’s) concern and get back to (the FDA) ASAP along with the other companies.” During the inspection, the firm provided copies of an audit report titled BRCGS Food Safety, Certificate of Registration, NSF Certificate of Conformity, and an FDA Establishment Inspection Report from their foreign supplier (redacted). They also provided a SAI Global Certificate of Conformity for (redacted), the manufacturer of (redacted). The firm did not provide any documents regarding their foreign suppliers (redacted) or (redacted), both located in (redacted).

The firms significant violations of the FSVP regulation are as follows:

  1. The firm did not develop, maintain, or follow an FSVP as required. Specifically, they did not develop an FSVP for each of the following foods:
  • (Redacted) tea bags imported from (redacted) located in (redacted)
  • (Redacted) imported from (redacted) located in (redacted)
  1. For Creamy Caramels with Sea Salt from their foreign supplier (redacted), although the firm provided documents regarding their foreign supplier, they did not meet their requirements to conduct a hazard analysis, they did not evaluate their foreign supplier’s performance, nor did they perform foreign supplier verification activities. 

The full warning letter can be viewed here.

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