FDA Inspection
AptaPharma Inc.AptaPharma Inc. – FDA Inspection, Aug 14, 2026
Record Details
This FDA Inspection record concerns AptaPharma Inc., with an inspection on August 14, 2026, issued by the New Jersey District Office, covering human drugs.
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ID · 5a27f40e-6ca9-448c-a9e6-9ab663ccfcec
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1331256
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
2- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.166(a)(3)Valid stability test methods
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Other FDA inspections of AptaPharma Inc.
5| Date | Classification | Office | Project area |
|---|---|---|---|
| October 24, 2024 | Not classified | New Jersey District Office | |
| May 15, 2023 | Not classified | New Jersey District Office | |
| September 25, 2019 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| March 16, 2018 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| June 23, 2014 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for AptaPharma Inc.
- FDA Inspection 1231140 - 2024-10-24
- FDA Inspection 1205203 - 2023-05-15
- FDA Inspection 1102699 - 2019-09-25
- FDA Inspection 1045668 - 2018-03-16
- FDA Inspection 884304 - 2014-06-23
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