PTI Georgia (Pharma Tech Industries)

United States
Oral Solid Dose Semi-solids & Liquids Packaging & Labeling
Program data pending ClinicalTrials.gov matching
Profiled
Not yet scored
✓ FDA Inspections (1) ○ Clinical Trials ○ SEC Filings ○ Press ○ EMA GMP ○ MHRA GMP ✓ HC GMP (1)

Quick Facts: PTI Georgia (Pharma Tech Industries)

Signal Score
Profiled, not yet scored. Scores are published after regulatory evidence is attached and reviewed. How scoring works
Headquarters
United States
Website
Modalities
Oral Solid Dose, Semi-solids & Liquids, Packaging & Labeling
Active Programs
No ClinicalTrials.gov matches confirmed
Data Sources
FDA Data Dashboard, ClinicalTrials.gov, SEC EDGAR, press monitoring

About PTI Georgia (Pharma Tech Industries)

PTI Georgia (Pharma Tech Industries) is a contract development and manufacturing organization (CDMO). Capabilities: Oral Solid Dose, Semi-solids & Liquids, Packaging & Labeling. 1 manufacturing site registered with the U.S. FDA and Health Canada. Website: https://pharma-tech.com/

Signal Score

Profiled, not yet scored. Scores are published after regulatory evidence is attached and reviewed. How scoring works

PTI Georgia (Pharma Tech Industries) FDA Inspection History

2026-01
NAI VAI OAI
Date Site Type Observations Classification
2026-01-16
PTI Georgia, LLC
Royston, Georgia Company-level
Drug Quality Assurance Yes Voluntary Action Indicated (VAI)
Source: FDA Data Dashboard · Retrieved Oct 31, 2026

PTI Georgia (Pharma Tech Industries) FDA 483 Findings 9 observations · 2026-01-16 → 2026-01-16 ?

By subsystem

  • Documentation & Records 3 (33.3%)
  • Equipment & Facilities 2 (22.2%)
  • Data Integrity 2 (22.2%)
  • CAPA 2 (22.2%)

By severity

  • 5 — Critical: 2
  • 3 — Moderate: 2
  • 2 — Minor: 5
  • Repeat observations: 0

Most severe findings

  • Critical (5) Data Integrity 2026-01-16 21 CFR 211.160(a)
    Lab controls established, including changes

    "The establishment of specifications, sampling plans, test procedures and laboratory control mechanisms including any changes thereto, are not drafted by the appropriate organizational unit and reviewed and approved by the quality control unit. Electronic records are used, but they do not meet audit trail requirements to ensure that they are trustworthy, reliable and generally equivalent to paper records."

  • Critical (5) Data Integrity 2026-01-16 21 CFR 211.194(a)
    Complete test data included in records

    "Laboratory records do not include complete data derived from all tests, examinations and assay necessary to assure compliance with established specifications and standards. Electronic records are used, but they do not meet audit trail requirements to ensure that they are trustworthy, reliable and generally equivalent to paper records."

  • Moderate (3) CAPA 2026-01-16 21 CFR 211.192
    Investigations of discrepancies, failures

    "There is a failure to thoroughly review any unexplained discrepancy whether or not the batch has been already distributed."

Hiring Activity Beta

Built from public job postings when a company's own roles can be read. Job postings are signals, not statements by the company; each one below links to the original. How we collect this
No hiring data yet. We haven't found a public jobs feed for this company.
Source: public careers pages · Checked Oct 30, 2026

Frequently Asked Questions About PTI Georgia (Pharma Tech Industries)

How many FDA inspections does PTI Georgia (Pharma Tech Industries) have on record?
CDMO Signal tracks 1 FDA inspection for PTI Georgia (Pharma Tech Industries), sourced from the FDA inspection database. See the full inspection history above.
Has PTI Georgia (Pharma Tech Industries) received an FDA warning letter?
CDMO Signal has no FDA warning letters on record for PTI Georgia (Pharma Tech Industries).
Does PTI Georgia (Pharma Tech Industries) have a CDMO Signal Score?
Not yet. PTI Georgia (Pharma Tech Industries) is profiled, not yet scored. Scores are published after regulatory evidence is attached and reviewed.
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