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.
Woobo LLC dba Purunchon Inc.
Fullerton, 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 Jan. 20 warning letter, the FDA described a Sept. 11 through 16, 2020, remote Foreign Supplier Verification Program (FSVP) inspection at Woobo LLC dba Purunchon Inc.
The FDA’s inspection revealed 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, including one unnamed item:
- Napa cabbage kimchi imported from (redacted)
- Soybean paste imported from (redacted)
- (redacted) imported from (redacted)
The full warning letter can be viewed here.
UCC Ueshima Coffee Company America Inc.
San Francisco, 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 Jan. 29 warning letter, the FDA described an Aug. 27-28, Sept. 1-3, 8-9 and 11, 2020, Foreign Supplier Verification Program (FSVP) inspection of FSVP records that UCC Ueshima Coffee America Inc. submitted electronically.
The FDA’s inspection revealed 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:
- UCC black coffee (ready-to-drink) imported from (redacted)
- UCC green tea (ready-to-drink) imported from (redacted)
- UCC Hawaii Kona coffee (ready-to-drink) imported from (redacted)
During FDA inspection the firm provided an audit certificate for their supplier (redacted); however, they did not provide a record of their review of this document or explain how it would apply to their FSVP program. The firm also provided two other documents, an audit certificate and supplier questionnaire, but it was not clear whether they were for one of the identified suppliers.
For thermally processed low-acid foods packaged in hermetically sealed containers– low-acid canned foods — with respect to those microbiological hazards that are controlled by following 21 CFR part 113, the firm must verify and document that the food was produced in accordance with 21 CFR part 113. The firm did not verify and document that their products – UCC black coffee (ready-to-drink), UCC green tea (ready-to-drink), and UCC Hawaii Kona coffee (ready-to-drink) – low-acid canned foods, were produced in accordance with 21 CFR part 113.
The full warning letter can be viewed here.
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