FDA Inspection
Compounding Pharmacy of AmericaCompounding Pharmacy of America – FDA Inspection, May 21, 2015
Record Details
This FDA Inspection record concerns Compounding Pharmacy of America, with an inspection on May 21, 2015, issued by the Center for Drug Evaluation and Research, covering drugs.
- Inspection Date
- May 21, 2015
- Product Type
- Drugs
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ID · 968dfaf1-1048-4373-b910-ad14a128c24d
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 928801
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Enforcement
- 483 Response
FDA Citations
16- 21 CFR 211.42(c)(10)(iii)Air Supply
- 21 CFR 211.42(c)(10)(ii)Temperature / Humidity Controls
- 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 211.28(a)Clothing appropriate for duties performed
- 21 CFR 211.94(c)Containers & Closures Clean, Sterilized, Pyrogen-free
- 21 CFR 211.167(a)Sterility/pyrogen-free testing
- 21 CFR 211.113(b)Procedures for sterile drug products
- 21 CFR 211.84(d)(2)Reports of Analysis (Components)
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Other FDA inspections of Compounding Pharmacy of America
1| Date | Classification | Office | Project area |
|---|---|---|---|
| February 1, 2018 | Not classified | New Orleans District Office |
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