FDA Inspection
Advance Pharmaceutical IncAdvance Pharmaceutical Inc – FDA Inspection, Feb 14, 2011
Record Details
This FDA Inspection record concerns Advance Pharmaceutical Inc, with an inspection on February 14, 2011, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Advance Pharmaceutical Inc
- Inspection Date
- February 14, 2011
- Product Type
- Drugs
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ID · 281bc6d3-9e5d-4e48-8031-039199a81dcc
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 709608
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
5- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.28(a)Protective Apparel Not Worn
- 21 CFR 211.166(a)Lack of written stability program
- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 211.180(e)(2)Items to cover on annual reviews
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Other FDA inspections of Advance Pharmaceutical Inc
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|---|---|---|---|
| February 27, 2025 | VAI | New York District Office | Drug Quality Assurance |
| December 13, 2018 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| July 6, 2017 | VAI | Center for Veterinary Medicine | Monitoring of Marketed Animal Drugs, Feed, and Devices |
| December 2, 2015 | OAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| March 6, 2015 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
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