FDA Inspection
PTI Georgia, LLCPTI Georgia, LLC – FDA Inspection, Jan 11, 2018
Record Details
This FDA Inspection record concerns PTI Georgia, LLC, with an inspection on January 11, 2018, issued by the Center for Drug Evaluation and Research, covering drugs.
- Person
- Rachael L. Derby (Issuing Officer)
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ID · ff2711bc-0e8b-4c71-be56-c8d4881ac0e4
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1037509
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
2- 21 CFR 211.160(b)(4)Calibration - at intervals, written program, remedial action
- 21 CFR 211.22(d)Procedures not in writing, fully followed
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Other FDA inspections of PTI Georgia, LLC
5| Date | Classification | Office | Project area |
|---|---|---|---|
| January 16, 2026 | VAI | Atlanta District Office | Drug Quality Assurance |
| February 6, 2020 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| November 21, 2014 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| March 11, 2011 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| October 17, 2008 | NAI | Center for Food Safety and Applied Nutrition | Colors and Cosmetics Technology |
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