FDA Inspection
Absolute Pharmacy, LLCAbsolute Pharmacy, LLC – FDA Inspection, Nov 19, 2014
Record Details
This FDA Inspection record concerns Absolute Pharmacy, LLC, with an inspection on November 19, 2014, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Absolute Pharmacy, LLC
- Inspection Date
- November 19, 2014
- Product Type
- Drugs
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ID · e0291d84-417d-4fa0-9713-1ef1b6d8da3d
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 906086
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
12- 21 CFR 211.42(c)(10)(iii)Air Supply
- 21 CFR 211.42(c)(10)(v)Cleaning System
- 21 CFR 211.42(c)(10)(iv)Environmental Monitoring System
- 21 CFR 211.188Prepared for each batch, include complete information
- 21 CFR 211.84(d)(6)Objectionable microbiological contamination
- 21 CFR 211.113(b)Procedures for sterile drug products
- 21 CFR 211.113(b)Validation lacking for sterile drug products
- 21 CFR 211.28(a)Protective Apparel Not Worn
- 21 CFR 211.165(a)Testing and release for distribution
- 21 CFR 211.94(d)Written Procedures to Remove Pyrogens
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Other FDA inspections of Absolute Pharmacy, LLC
1| Date | Classification | Office | Project area |
|---|---|---|---|
| April 11, 2016 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
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