# FDA 483 - PTI Georgia, LLC - February 06, 2020

Source: https://www.keypedia.com/records/483/pti-georgia-llc/517566fa-2ffa-4d3d-b9fe-e58a127b9e24

> FDA 483 for PTI Georgia, LLC on February 06, 2020. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: PTI Georgia, LLC
- Inspection Date: 2020-02-06
- Product Type: drugs
- Office Name: Atlanta District Office
- Summary: PTT Royston LLC, a drug manufacturer in Royston, GA, was cited for multiple significant deficiencies during an FDA inspection. Observations included failures in complaint investigations, premature product release without complete testing, inadequate annual product reviews, and deficiencies in quality control unit procedures and laboratory controls. These issues indicate a lack of adherence to good manufacturing practices.

## Related Officers

- [Susan O. Oladeji](https://www.keypedia.com/people/susan-o-oladeji/307277f8-7704-4ada-8d8d-d77118c6cb77)

Company: https://www.keypedia.com/companies/pti-georgia-llc/a1dea629-43b4-4dda-963c-1b320b0311a5

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