FDA Inspection
Dakota Laboratories, LLCDakota Laboratories, LLC – FDA Inspection, Apr 5, 2012
Record Details
This FDA Inspection record concerns Dakota Laboratories, LLC, with an inspection on April 5, 2012, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Dakota Laboratories, LLC
- Inspection Date
- April 5, 2012
- Product Type
- Drugs
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ID · 259a93e4-811b-4ddb-87d5-0be1a06ba155
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 776780
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
5- 21 CFR 211.113(b)Procedures for sterile drug products
- 21 CFR 211.113(b)Validation lacking for sterile drug products
- 21 CFR 211.22(c)Approve or reject procedures or specs
- 21 CFR 211.192Investigations of discrepancies, failures
- 21 CFR 211.165(c)Sampling and testing plans not followed
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Other FDA inspections of Dakota Laboratories, LLC
2| Date | Classification | Office | Project area |
|---|---|---|---|
| August 31, 2011 | OAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| June 24, 2010 | OAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
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