As portion of its enforcement activities, the Meals and Drug Administration sends warning letters to entities below its jurisdiction. Some letters are now not posted for public explore except weeks or months after they are despatched. Industry householders relish 15 days to answer to FDA warning letters. Warning letters typically are now not issued except a firm has been given months to years to lovely considerations. The FDA repeatedly redacts parts of warning letters posted for public explore.


Woobo LLC dba Purunchon Inc.


Fullerton, CA


An import firm in California is on witness from the FDA for now not having FSVPs for quite loads of imported food merchandise.

In a Jan. 20 warning letter, the FDA described a Sept. 11 thru 16, 2020, a ways-off Foreign Seller Verification Program (FSVP) inspection at Woobo LLC dba Purunchon Inc.

The FDA’s inspection printed the agency used to be now not in compliance with FSVP guidelines and resulted in the issuance of an FDA Win 483a. The loads of violations are as follows:

The agency didn’t manufacture, keep, and practice an FSVP. Namely, they didn’t manufacture an FSVP for every of the following foods, at the side of one unnamed item:

  • Napa cabbage kimchi imported from (redacted)
  • Soybean paste imported from (redacted)
  • (redacted) imported from (redacted)

The pudgy warning letter can even be considered here.

UCC Ueshima Coffee Firm The USA Inc.


S
an Francisco, CA


An import firm in California is on witness from the FDA for now not having FSVPs for quite loads of imported food merchandise.

In a Jan. 29 warning letter, the FDA described an Aug. 27-28, Sept. 1-3, 8-9 and 11, 2020,  Foreign Seller Verification Program (FSVP) inspection of FSVP records that UCC Ueshima Coffee The USA Inc. submitted electronically.

The FDA’s inspection printed the agency used to be now not in compliance with FSVP guidelines and resulted in the issuance of an FDA Win 483a. The loads of violations are as follows:

The agency didn’t manufacture, keep, and practice an FSVP. Namely, they didn’t manufacture an FSVP for every of the following foods:

  •  UCC sad coffee (ready-to-drink) imported from (redacted)
  •  UCC inexperienced tea (ready-to-drink) imported from (redacted)
  •  UCC Hawaii Kona coffee (ready-to-drink) imported from (redacted)

Right thru FDA inspection the agency supplied an audit certificates for his or her supplier (redacted); nonetheless, they didn’t present a file of their review of this record or display how it would discover to their FSVP program. The agency also supplied two other documents, an audit certificates and supplier questionnaire, nonetheless it used to be now not decided whether or not they relish been for one amongst the identified suppliers.

For thermally processed low-acid foods packaged in hermetically sealed containers– low-acid canned foods — with appreciate to these microbiological hazards that are managed by following 21 CFR portion 113, the agency must verify and record that the food used to be produced based mostly totally on 21 CFR portion 113. The agency didn’t verify and record that their merchandise – UCC sad coffee (ready-to-drink), UCC inexperienced tea (ready-to-drink), and UCC Hawaii Kona coffee (ready-to-drink) – low-acid canned foods, relish been produced based mostly totally on 21 CFR portion 113.

The pudgy warning letter can even be considered here.

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