# FDA 483 - National Genetics Institute - March 02, 2022

Source: https://www.globalkeysolutions.net/records/483/national-genetics-institute/e40b0388-17d8-4643-8632-f4c8538ceba5

> FDA 483 for National Genetics Institute on March 02, 2022. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: National Genetics Institute
- Inspection Date: 2022-03-02
- Product Type: biologics
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: National Genetics Institute, a contract testing laboratory in Los Angeles, CA, was cited for three observations during an FDA inspection. The firm failed to submit required supplements for changes involving non-licensed applications and lacked proper documentation for reporting these tests. Additionally, there were no written procedures for personnel to change Personal Protective Equipment when moving between different testing areas, and storage controls for both licensed and unlicensed samples and products were found to be inadequate, risking mix-ups.

## Related Documents

- [483 - Unknown Date](https://www.globalkeysolutions.net/records/483/national-genetics-institute/4506b0f5-f1dc-43e5-abe2-b77a07b1a5f1)
- [EIR - 2018-12-04](https://www.globalkeysolutions.net/records/eir/national-genetics-institute/7019f19b-cb11-40a1-b29a-33942b83d1c2)

## Related Officers

- [Lewis K. Antwi](https://www.globalkeysolutions.net/people/lewis-k-antwi/8ab4f1c7-8b5b-4556-98a4-6edc3bc49470)
- [issuing_officer](https://www.globalkeysolutions.net/people/omotunde-osunsanmi/41c6ef66-1d5c-4940-8b1f-628da20cde34)

Company: https://www.globalkeysolutions.net/companies/national-genetics-institute/ac8d4601-6cbd-4b3e-a859-f76837772727

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