FDA Inspection
Oakdell Compounding Pharmacy LLCOakdell Compounding Pharmacy LLC – FDA Inspection, Mar 1, 2013
Record Details
This FDA Inspection record concerns Oakdell Compounding Pharmacy LLC, with an inspection on March 1, 2013, issued by the Center for Drug Evaluation and Research, covering drugs.
- Inspection Date
- March 1, 2013
- Product Type
- Drugs
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ID · fea6e869-4925-4411-956f-c9888ddc9c18
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 821399
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
7- 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 211.113(b)Procedures for sterile drug products
- 21 CFR 211.113(b)Validation lacking for sterile drug products
- 21 CFR 211.42(c)(10)Aseptic Processing Area
- 21 CFR 211.166(a)Lack of written stability program
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Other FDA inspections of Oakdell Compounding Pharmacy LLC
2| Date | Classification | Office | Project area |
|---|---|---|---|
| March 29, 2017 | Not classified | Dallas District Office | |
| March 1, 2013 | OAI | Center for Veterinary Medicine | Monitoring of Marketed Animal Drugs, Feed, and Devices |
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