FDA Inspection
Kirk Pharmaceuticals, LLCKirk Pharmaceuticals, LLC – FDA Inspection, Jul 2, 2009
Record Details
This FDA Inspection record concerns Kirk Pharmaceuticals, LLC, with an inspection on July 2, 2009, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Kirk Pharmaceuticals, LLC
- Inspection Date
- July 2, 2009
- Product Type
- Drugs
View Company Profile
ID · 81a7a25b-cd9d-49d6-a0b8-a54ae4958021
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 594632
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
7- 21 CFR 211.101(c)Weighing/measuring/subdividing supervision
- 21 CFR 211.165(f)Failing drug products not rejected
- 21 CFR 211.192Extent of discrepancy, failure investigations
- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.192Investigations of discrepancies, failures
- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 211.180(e)(1)Review of representative number of batches
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