FDA Inspection
Pillar5 Pharma Inc.Pillar5 Pharma Inc. – FDA Inspection, Feb 7, 2025
Record Details
This FDA Inspection record concerns Pillar5 Pharma Inc., with an inspection on February 7, 2025, issued by the Office of Inspections and Investigations, covering human drugs.
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ID · 9bde498e-2566-4025-8c5b-53bacfb5ac30
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1261773
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
9- 21 CFR 211.113(b)Validation lacking for sterile drug products
- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.166(a)Written program not followed
- 21 CFR 211.170(b)Annual visual exams of drug products
- 21 CFR 211.170(b)Drug product reserve containers
- 21 CFR 211.192Investigations of discrepancies, failures
- 21 CFR 211.192Written record of investigation incomplete
- 21 CFR 211.194(d)Laboratory equipment calibration records
- 21 CFR 211.42(c)(10)(v)Cleaning System
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Other FDA inspections of Pillar5 Pharma Inc.
9| Date | Classification | Office | Project area |
|---|---|---|---|
| June 5, 2026 | Not classified | Office of Inspections and Investigations | Drug Quality Assurance |
| December 15, 2023 | OAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| February 21, 2020 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| May 17, 2018 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| January 26, 2018 | VAI | Center for Veterinary Medicine | Pre-Approval Eval. of Animal Drugs and Food Additives |
Other documents for Pillar5 Pharma Inc.
- FDA Inspection 1323174 - 2026-06-05
- FDA Inspection 1226692 - 2023-12-15
- FDA Inspection 1119040 - 2020-02-21
- FDA Inspection 1058599 - 2018-05-17
- FDA Inspection 1038745 - 2018-01-26
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