# FDA 483 - Purisys LLC - March 13, 2024

Source: https://www.keypedia.com/records/483/purisys-llc/c79c1f11-c5cc-42fd-9180-7349960c90d9

> FDA 483 for Purisys LLC on March 13, 2024. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Purisys LLC
- Inspection Date: 2024-03-13
- Product Type: drugs
- Office Name: Atlanta District Office
- Summary: An FDA inspection of Purisys LLC, an API and intermediate manufacturer in Athens, GA, revealed significant unsanitary conditions and pest control issues throughout the facility. Inspectors observed microbiological discoloration, flies, bird droppings, spiders, and a roach in various production and storage areas. Additionally, the firm lacked adequate written procedures for the handling and cleaning of raw material containers, particularly those exposed to the environment.

## Related Officers

- [J'Maica J. Hunter](https://www.keypedia.com/people/jmaica-j-hunter/173f731f-4dc4-4ef2-8cb3-72993cb91119)
- [Pharmaceutical Specialist/ Investigator ](https://www.keypedia.com/people/veronica-fuentes/50ea657f-39e6-4d97-a627-86339df3fbe6)

Company: https://www.keypedia.com/companies/purisys-llc/1cf69929-9d86-4fb5-b06c-a5533522ecd5

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