FDA Inspection
Pfizer Pharmaceuticals LLCPfizer Pharmaceuticals LLC – FDA Inspection, Sep 1, 2011
Record Details
This FDA Inspection record concerns Pfizer Pharmaceuticals LLC, with an inspection on September 1, 2011, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Pfizer Pharmaceuticals LLC
- Inspection Date
- September 1, 2011
- Product Type
- Drugs
View Company Profile
ID · 080592f3-a188-4db4-a419-17ded0e513c7
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 742294
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
6- 21 CFR 314.81(b)(1)(ii)Contamination, chemical or physical change, deterioration
- 21 CFR 211.110(a)Control procedures to monitor and validate performance
- 21 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.170(b)Annual visual exams of drug products
- 21 CFR 211.22(d)Procedures not in writing, fully followed
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Other FDA inspections of Pfizer Pharmaceuticals LLC
1| Date | Classification | Office | Project area |
|---|---|---|---|
| March 19, 2009 | VAI | Center for Drug Evaluation and Research | Postmarket Surv. and Epidemiology |
Other documents for Pfizer Pharmaceuticals LLC
- FDA Inspection 571285 - 2009-03-19
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