# FDA 483 - Purac America, Inc. - August 02, 2024

Source: https://www.keypedia.com/records/483/purac-america-inc/3f0a4afc-6b77-4289-8be5-09cea6c02f44

> FDA 483 for Purac America, Inc. on August 02, 2024. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Purac America, Inc.
- Inspection Date: 2024-08-02
- Product Type: drugs
- Office Name: Atlanta District Office
- Summary: The FDA inspection of Purac America Inc. in Tucker, GA, revealed significant deficiencies across its quality control unit, laboratory controls, equipment maintenance, cleanroom operations, and personnel gowning procedures. The firm failed to develop a quality management system for excipients, maintain adequate electronic record controls, and ensure proper cleaning and environmental conditions. These issues indicate a lack of robust systems to prevent contamination and ensure product quality.

## Related Officers

- [Consumer Safety Officer](https://www.keypedia.com/people/steven-a-brettler/2a356468-f9da-4b68-a3a1-472567e58e45)
- [Pharmaceutical Specialist/ Investigator ](https://www.keypedia.com/people/veronica-fuentes/50ea657f-39e6-4d97-a627-86339df3fbe6)

Company: https://www.keypedia.com/companies/purac-america-inc/3b66349d-3573-4f48-9fcb-0db384550fcf

Office: https://www.keypedia.com/offices/atlanta-district-office/7586d99a-288e-49d1-8c3d-d88b7354b7a7