# FDA 483 - PTI Georgia, LLC - January 16, 2026

Source: https://www.keypedia.com/records/483/pti-georgia-llc/e269afbe-c3eb-446c-9752-d0b5cb90d2fe

> FDA 483 for PTI Georgia, LLC on January 16, 2026. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: PTI Georgia, LLC
- Inspection Date: 2026-01-16
- Product Type: drugs
- Office Name: FDA District Office — Atlanta, Georgia
- Summary: PTI Georgia, LLC dba Pharma Tech Industries, a contract manufacturer in Royston, GA, was cited for significant deficiencies across its laboratory, production, and quality systems during an FDA inspection. Observations include inadequate control over specifications and electronic records, insufficient record retention, failure to establish robust production procedures, and deficiencies in discrepancy investigations and equipment maintenance. These issues indicate systemic problems in maintaining cGMP compliance.

## Related Documents

- [483 - 2020-02-06](https://www.keypedia.com/records/483/pti-georgia-llc/517566fa-2ffa-4d3d-b9fe-e58a127b9e24)
- [483 - 2026-01-16](https://www.keypedia.com/records/483/pti-georgia-llc/c54c528f-5981-4b74-807f-d8dbd0361bde)

## 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/pti-georgia-llc/a1dea629-43b4-4dda-963c-1b320b0311a5

Office: https://www.keypedia.com/offices/fda-district-office-atlanta-georgia/bae3b8c4-4161-4e9f-b5d1-e0e80b6abd43