FDA Inspection
Corwood Labs IncCorwood Labs Inc – FDA Inspection, Apr 8, 2009
Record Details
This FDA Inspection record concerns Corwood Labs Inc, with an inspection on April 8, 2009, issued by the Center for Veterinary Medicine, covering veterinary.
- Company
- Corwood Labs Inc
- Inspection Date
- April 8, 2009
- Product Type
- Veterinary
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ID · 9d559314-b9dc-42b7-9390-8a467eff620f
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 578930
- FDA center
- Animal Drugs & Feeds
- Project area
- Monitoring of Marketed Animal Drugs, Feed, and Devices
FDA Citations
12- 21 CFR 211.166(b)Adequate number of batches on stability
- 21 CFR 211.198(b)(2)Complaint Investigation/Follow-Up Findings
- 21 CFR 211.110(a)Control procedures to monitor and validate performance
- 21 CFR 211.165(f)Failing drug products not rejected
- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.84(d)(2)Reports of Analysis (Components)
- 21 CFR 211.165(e)Test methods
- 21 CFR 211.160(b)(4)Calibration - at intervals, written program, remedial action
- 21 CFR 211.100(a)Absence of Written Procedures
- 21 CFR 211.192Investigations of discrepancies, failures
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