# FDA 483 - GMP Laboratories of America Inc - December 16, 2024

Source: https://www.globalkeysolutions.net/records/483/gmp-laboratories-of-america-inc/69439d7d-b1e1-4dee-84c2-aa125de8e6c7

> FDA 483 for GMP Laboratories of America Inc on December 16, 2024. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: GMP Laboratories of America Inc
- Inspection Date: 2024-12-16
- Product Type: drugs
- Office Name: Los Angeles District Office
- Summary: An FDA inspection of GMP Laboratories of America Inc. in Anaheim, CA, revealed critical deficiencies in laboratory data management, production controls, and documentation practices. The firm failed to maintain complete and reviewed laboratory records, establish critical process parameters for manufacturing, and document operations contemporaneously. These issues, along with inadequate equipment cleaning procedures, raise significant concerns about data integrity, product quality, and potential cross-contamination for their homeopathic drug products.

## Related Documents

- [483 - 2020-01-14](https://www.globalkeysolutions.net/records/483/gmp-laboratories-of-america-inc/822b1182-b0fd-463a-ada8-54140ac5abfe)

## Related Officers

- [Consumer Safety Officer](https://www.globalkeysolutions.net/people/tiara-m-brown/bbc93754-69de-4379-b9f5-f85ea4c8b0e9)
- [Stryker, Regulatory Affairs](https://www.globalkeysolutions.net/people/gunneet-kaur/e2823ed9-44f2-4553-8984-895ef8c7eece)

Company: https://www.globalkeysolutions.net/companies/gmp-laboratories-of-america-inc/2da37103-3d54-46ce-ad06-a2574d45afa9

Office: https://www.globalkeysolutions.net/offices/los-angeles-district-office/edcf1dfe-596a-43b8-8df4-07d9cd94763b