FDA Inspection
Wedgewood Village Pharmacy, LLCWedgewood Village Pharmacy, LLC – FDA Inspection, Sep 29, 2015
Record Details
This FDA Inspection record concerns Wedgewood Village Pharmacy, LLC, with an inspection on September 29, 2015, issued by the Center for Drug Evaluation and Research, covering drugs.
- Inspection Date
- September 29, 2015
- Product Type
- Drugs
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ID · bf40c6ec-2706-4f48-a291-506bf21904b8
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 943712
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Enforcement
- 483 Response
FDA Citations
6- 21 CFR 211.42(c)(10)(iv)Environmental Monitoring System
- 21 CFR 211.28(a)Clothing appropriate for duties performed
- 21 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
- 21 CFR 211.113(b)Procedures for sterile drug products
- 21 CFR 211.165(a)Testing and release for distribution
- 21 CFR 211.22(d)Procedures not in writing, fully followed
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Other FDA inspections of Wedgewood Village Pharmacy, LLC
2| Date | Classification | Office | Project area |
|---|---|---|---|
| March 24, 2022 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| February 11, 2013 | OAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
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