As a part of its legislation enforcement actions, the Meals and Drug Administration sends warning letters to entities underneath its jurisdiction. Some letters are usually not posted for public view till weeks or months after they’re despatched. Enterprise homeowners have 15 days to answer FDA warning letters. Warning letters are sometimes not issued till the corporate has been given months or years to right the issues.
Kyawkhin Inc.
Fort Wayne, Indiana, USA
A meals firm in Indiana obtained a discover from the FDA for not having FSVP for a number of imported meals merchandise.
In a warning letter dated September 20, 2023, the FDA described a International Provider Verification Program (FSVP) inspection from August 15 to 17, 2023, of Kyawkhin Inc. in Fort Wayne, IN.
The FDA inspection revealed that the corporate was not in compliance with FSVP laws and resulted within the issuance of an FDA Kind 483a. The numerous violations are the next:
The corporate didn’t develop, keep or observe an FSVP. Particularly, they didn’t develop an FSVP for every of the next meals:
- Balachong fried chili paste imported from (written up)located in (written up)
- Imported peanut sandwich (written up)located in (written up)
- Cypro Tone drink base imported from (written up)located in (written up)
The complete warning letter could be considered right here.
Distributor Jocorena Inc.
Deer Park, New York, USA
A meals firm in New York obtained a discover from the FDA for not having FSVP for a number of imported meals merchandise.
In a warning letter dated Nov. 30, 2023, the FDA described a International Provider Verification Program (FSVP) inspection from Aug. 21 to Sept. eight, 2023, of Distribuidora Jocorena Inc. in Deer Park, New York.
The FDA inspection revealed that the corporate was not in compliance with FSVP laws and resulted within the issuance of an FDA Kind 483a. The numerous violations are the next:
The corporate didn’t develop, keep or observe an FSVP. Particularly, they didn’t develop an FSVP for every of the next meals:
- Pinole (corn flour) imported from (written up)located in (written up)
- Frozen corn tamale imported from (written up)located in (written up)
- Dried purple beans (kidney beans) imported from (written up)located in (written up)
The complete warning letter could be considered right here.
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