FDA-Inspected Site

PTI Georgia, LLC

4 FDA inspections are on record for PTI Georgia, LLC in Royston, United States.

483· Form 483 issued

Royston, United States · Last updated August 15, 2026

Overview

  • 4 FDA inspections are on record.
  • 4 inspections produced a Form 483.
  • The most recent recorded inspection date is 2026-01-16.

At a glance

Inspections

4

Form 483s

4

EIRs

0

Last outcome

Form 483

Inspection history

FDA inspections on record, most recent first.

InspectionCategoryOutcomeForm 483
8 Jan 2026 – 16 Jan 2026Human Drugs483View 483 →
3 Feb 2020 – 6 Feb 2020Human Drugs483View 483 →
8 Jan 2018 – 11 Jan 2018Human Drugs483View 483 →
17 Nov 2014 – 21 Nov 2014Human Drugs483On file

Observations on record

Form 483 observations cited at this site, most recent first.

16 Jan 2026
21 CFR 211.100(a)

Absence of Written Procedures

Cited by Veronica Fuentes, Steven A Brettler

16 Jan 2026
21 CFR 211.100(a)

Changes to Procedures Not Reviewed, Approved

Cited by Veronica Fuentes, Steven A Brettler

16 Jan 2026
21 CFR 211.160(a)

Lab controls established, including changes

Cited by Veronica Fuentes, Steven A Brettler

16 Jan 2026
21 CFR 211.180(b)

Record maintenance 1 year (except exempt OTC)

Cited by Veronica Fuentes, Steven A Brettler

16 Jan 2026
21 CFR 211.180(e)

Records reviewed annually

Cited by Veronica Fuentes, Steven A Brettler

Investigators

FDA investigators tied to this site in the record.

Jawaid Hamid1 insp.

Recurring citations

CFR citation patterns observed across this site's inspections.

CitationWhat it coversCited
21 CFR 211.192Cited across public-safe Form 483 observations3x
21 CFR 211.100(a)Cited across public-safe Form 483 observations2x
21 CFR 211.160(a)Cited across public-safe Form 483 observations2x
21 CFR 211.22(d)Cited across public-safe Form 483 observations2x
21 CFR 211.160(b)Cited across public-safe Form 483 observations1x
21 CFR 211.160(b)(4)Cited across public-safe Form 483 observations1x
21 CFR 211.165(a)Cited across public-safe Form 483 observations1x
21 CFR 211.180(b)Cited across public-safe Form 483 observations1x
21 CFR 211.180(e)Cited across public-safe Form 483 observations1x
21 CFR 211.180(e)(2)Cited across public-safe Form 483 observations1x
21 CFR 211.194(a)Cited across public-safe Form 483 observations1x
21 CFR 211.67(a)Cited across public-safe Form 483 observations1x

Full site report

Get the verbatim findings behind PTI Georgia, LLC's 4 Form 483s

Source PDFs, verbatim observations, and recurring CFR citations, so your team knows what this site gets cited for.

  • The site's full inspection history, with every Form 483 and its outcome
  • Warning letters and recalls tied to the company behind it
  • Whether recurring CFR citations get closed out or repeat