# FDA 483 - Cosmax Nbt Usa, Inc. - May 04, 2021

Source: https://www.keypedia.com/records/483/cosmax-nbt-usa-inc/45be9e82-9769-4033-935d-72dfb62e7fbe

> FDA 483 for Cosmax Nbt Usa, Inc. on May 04, 2021. Product: other. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Cosmax Nbt Usa, Inc.
- Inspection Date: 2021-05-04
- Product Type: other
- Office Name: Division of Human and Animal Food Operations - West III
- Summary: Cosmax NBT USA received a Form 483 for significant deficiencies in its quality control and manufacturing processes for dietary supplements. Observations included failing to reject out-of-specification components and finished products, using unvalidated testing methods, and not establishing appropriate specifications. The firm also faced issues with record-keeping, adherence to master manufacturing records, and failure to register as an acidified food manufacturer.

## Related Documents

- [483 - 2019-11-22](https://www.keypedia.com/records/483/cosmax-nbt-usa-inc/8b056f97-b3dd-451f-abf1-fbec91c43699)
- [WARNING_LETTER - 2021-05-04](https://www.keypedia.com/records/warning_letter/cosmax-nbt-usa-inc/be5cc8c2-c5c4-4f3a-a1db-f24bed77c9c2)

## Related Officers

- [Brook Shea](https://www.keypedia.com/people/brook-shea/442e6722-298f-4086-882a-d19c72580e0a)
- [Consumer Safety Officer/Investigator](https://www.keypedia.com/people/bing-lin/7037e34a-15df-4e81-bd35-bd91b9ab167a)

Company: https://www.keypedia.com/companies/cosmax-nbt-usa-inc/705afef0-93c0-450c-8dd5-aa038fc0bd41

Office: https://www.keypedia.com/offices/division-of-human-and-animal-food-operations-west-iii/2cda09a5-06c4-433f-9df0-0d7903a6efab