PTI Georgia, LLC – FDA Inspection, Jan 16, 2026

Record Details

This FDA Inspection record concerns PTI Georgia, LLC, with an inspection on January 16, 2026, issued by the Atlanta District Office, covering human drugs.

Company: PTI Georgia, LLC
Inspection Date: January 16, 2026
Product Type: Human Drugs
Office: Atlanta District Office
People: Steven A. Brettler (FDA Associated Person)
Veronica Fuentes (FDA Associated Person)

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ID · 9d00d119-c04f-4970-b6aa-42184490f19c

Inspection Facts

Voluntary Action Indicated (VAI)

Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.

Inspection number: 1282808
FDA center: Human Drugs
Project area: Drug Quality Assurance
Outcome: Form 483 issued, view the record

FDA Citations

21 CFR 211.100(a)Absence of Written Procedures
21 CFR 211.100(a)Changes to Procedures Not Reviewed, Approved
21 CFR 211.160(a)Lab controls established, including changes
21 CFR 211.180(b)Record maintenance 1 year (except exempt OTC)
21 CFR 211.180(e)Records reviewed annually
21 CFR 211.192Extent of discrepancy, failure investigations
21 CFR 211.192Investigations of discrepancies, failures
21 CFR 211.194(a)Complete test data included in records
21 CFR 211.67(a)Cleaning / Sanitizing / Maintenance

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Other FDA inspections of PTI Georgia, LLC

Date	Classification	Office	Project area
February 6, 2020	VAI	Center for Drug Evaluation and Research	Drug Quality Assurance
January 11, 2018	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