As a part of its enforcement actions, the Meals and Drug Management sends caution letters to entities underneath its jurisdiction. Some letters don’t seem to be posted for public view till weeks or months after they’re despatched. Industry house owners have 15 days to reply to FDA caution letters. Caution letters continuously don’t seem to be issued till an organization has been given months to years to proper issues.
Perfect Fiji Kava Inc.
Hayward, CA
An import corporate in California is on realize from the FDA for no longer having FSVPs for various imported meals merchandise.
In a Feb. 16 caution letter, the FDA described a Nov. 16, 2021, International Provider Verification Program (FSVP) inspection of Perfect Fiji Kava, Inc. in Hayward, CA.
The FDA’s inspection printed that the company was once no longer in compliance with FSVP laws and resulted within the issuance of an FDA Shape 483a. The numerous violations are as follows:
The company didn’t expand, care for, and apply an FSVP. In particular, they didn’t expand an FSVP for every of the next meals, together with every of the next meals merchandise imported from (redacted) positioned in (redacted):
- (Redacted) Crackers
- Snack Chips
- (Redacted) Noodles
The entire caution letter will also be seen right here.
International Imports Inc.
Kingwood, TX
An import corporate in Texas is on realize from the FDA for no longer having FSVPs for various imported meals merchandise.
In an April 7 caution letter, the FDA described a Dec. 15, 2021, via Jan. 5, 2022, International Provider Verification Program (FSVP) inspection of International Imports Inc. in Kingwood, TX.
The FDA’s inspection printed that the company was once no longer in compliance with FSVP laws and resulted within the issuance of an FDA Shape 483a. The numerous violations are as follows:
The company didn’t expand, care for, and apply an FSVP. In particular, they didn’t expand an FSVP for every of the next meals:
- Chopped Spinach imported from overseas provider (redacted), positioned in (redacted)
- Minimize Cauliflower imported from overseas providers (redacted), and (redacted), positioned in (redacted)
- Minimize Corn imported from overseas provider (redacted), positioned in (redacted)
- Diced Yellow Peaches imported from overseas provider (redacted), positioned in (redacted)
The entire caution letter will also be seen right here.
Bhan Kanom Thai Inc.
Los Angeles, CA
An import corporate in California is on realize from the FDA for no longer having FSVPs for various imported meals merchandise.
In a March 28 caution letter, the FDA described a Dec.6, 7, 9, 13 and 14, 2021, International Provider Verification Program (FSVP) inspection of Bhan Kanom Thai Inc in Los Angeles, CA.
The FDA’s inspection printed that the company was once no longer in compliance with FSVP laws and resulted within the issuance of an FDA Shape 483a. The numerous violations are as follows:
The company didn’t expand, care for, and apply an FSVP. In particular, they didn’t expand an FSVP for every of the next meals:
- Cookie Rolls – Natural imported from (redacted)
- (Redacted) Chip imported from (redacted)
- (Redacted) Dipping Sauce imported from (redacted)
The entire caution letter will also be seen right here.
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