FDA Inspection
Pharmakon Pharmaceuticals, Inc.Pharmakon Pharmaceuticals, Inc. – FDA Inspection, Mar 16, 2016
Record Details
This FDA Inspection record concerns Pharmakon Pharmaceuticals, Inc., with an inspection on March 16, 2016, issued by the Center for Drug Evaluation and Research, covering drugs.
- Inspection Date
- March 16, 2016
- Product Type
- Drugs
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ID · 75d52363-7a80-45cb-8486-be9ffc8da4a9
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 965166
- 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)(vi)Equipment to control conditions
- 21 CFR 211.42(c)(10)(v)Cleaning System
- 21 CFR 211.42(c)(10)(iv)Environmental Monitoring System
- 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 211.165(a)Testing and release for distribution
- 21 CFR 211.42(d)Penicillin processing area not kept separate
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Other FDA inspections of Pharmakon Pharmaceuticals, Inc.
2| Date | Classification | Office | Project area |
|---|---|---|---|
| April 8, 2014 | OAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| March 13, 2014 | OAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
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