# FDA 483 - GMP Laboratories of America Inc - January 14, 2020

Source: https://www.globalkeysolutions.net/records/483/gmp-laboratories-of-america-inc/822b1182-b0fd-463a-ada8-54140ac5abfe

> FDA 483 for GMP Laboratories of America Inc on January 14, 2020. 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: 2020-01-14
- Product Type: drugs
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: This FDA Form 483 was issued to R&C Laboratories of America Inc. in Anaheim, CA, following an inspection that identified significant deficiencies across multiple systems. The firm failed to follow quality control unit procedures, lacked adequate production and process controls including method validation, and exhibited issues with equipment maintenance and proper segregation of quarantined products. These observations indicate a general lack of adherence to current good manufacturing practices for homeopathic drug products.

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## Related Officers

- [Consumer Safety Officer, Drug Specialist](https://www.globalkeysolutions.net/people/taichun-qin/62349336-96d6-4452-9c20-9084204b86bf)

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

Office: https://www.globalkeysolutions.net/offices/division-of-pharmaceutical-quality-operations-iv/a2d2ff91-dc0f-433e-b91f-ca90ff8998b6