# FDA 483 - AMF Pharma LLC - January 16, 2024

Source: https://www.keypedia.com/records/483/amf-pharma-llc/0bdfb2df-f4aa-44ba-ad00-96b9e4b22b55

> FDA 483 for AMF Pharma LLC on January 16, 2024. Product: other. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: AMF Pharma LLC
- Inspection Date: 2024-01-16
- Product Type: other
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: AMP Pharma LLC, a dietary supplement manufacturer in Ontario, CA, received a Form 483 for significant deficiencies in establishing and approving specifications. The firm failed to define identity, purity, strength, and composition for incoming raw materials and finished products. Additionally, the company lacked established specifications and review processes for labels used in packaging.

## Related Officers

- [Sparky L Bartee](https://www.keypedia.com/people/sparky-l-bartee/d47e1703-b88e-409b-aaba-29b4c38545ef)

Company: https://www.keypedia.com/companies/amf-pharma-llc/c1f84bff-21ed-4830-8006-91bfcae831b4

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