FDA Inspection
PQ Pharmacy LLCPQ Pharmacy LLC – FDA Inspection, Jun 1, 2026
Record Details
This FDA Inspection record concerns PQ Pharmacy LLC, with an inspection on June 1, 2026, issued by the Florida District Office, covering human drugs.
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ID · 5c1e0996-0476-4942-9670-c96175437bdd
Inspection Facts
- Inspection number
- 1320766
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
7- 21 CFR 211.113(b)Procedures for sterile drug products
- 21 CFR 211.113(b)Validation lacking for sterile drug products
- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.192Investigations of discrepancies, failures
- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 211.63Equipment Design, Size and Location
- 21 CFR 211.68(a)Written calibration / inspection records not kept
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Other FDA inspections of PQ Pharmacy LLC
2| Date | Classification | Office | Project area |
|---|---|---|---|
| April 4, 2025 | OAI | Florida District Office | Drug Quality Assurance |
| October 27, 2022 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
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