FDA Inspection
Armstrong Pharmaceuticals, Inc.Armstrong Pharmaceuticals, Inc. – FDA Inspection, Nov 13, 2009
Record Details
This FDA Inspection record concerns Armstrong Pharmaceuticals, Inc., with an inspection on November 13, 2009, issued by the Center for Drug Evaluation and Research, covering drugs.
- Inspection Date
- November 13, 2009
- Product Type
- Drugs
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ID · 97b50200-6eeb-482d-8752-08a335a43bd2
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 632085
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
6- 21 CFR 211.63Equipment Design, Size and Location
- 21 CFR 211.192Investigations of discrepancies, failures
- 21 CFR 211.165(d)Acceptance/Rejection Levels
- 21 CFR 211.194(a)(2)Suitability of testing methods verified
- 21 CFR 211.160(b)(4)Instruments, apparatus, et. al. not meeting specs
- 21 CFR 211.67(b)Written procedures not established/followed
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Other FDA inspections of Armstrong Pharmaceuticals, Inc.
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|---|---|---|---|
| May 8, 2026 | VAI | New England District Office | Drug Quality Assurance |
| July 19, 2024 | VAI | Center for Drug Evaluation and Research | Bioresearch Monitoring |
| July 14, 2021 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| April 3, 2014 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| October 5, 2012 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
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