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 Veterinary Medicine, covering veterinary.
- Inspection Date
- March 1, 2013
- Product Type
- Veterinary
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ID · 8c072980-c826-45da-9d36-8b0ed732d9bd
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 821400
- FDA center
- Animal Drugs & Feeds
- Project area
- Monitoring of Marketed Animal Drugs, Feed, and Devices
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 Drug Evaluation and Research | Drug Quality Assurance |
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