FDA Inspection
Whitney Labs LPWhitney Labs LP – FDA Inspection, Nov 9, 2010
Record Details
This FDA Inspection record concerns Whitney Labs LP, with an inspection on November 9, 2010, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Whitney Labs LP
- Inspection Date
- November 9, 2010
- Product Type
- Drugs
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ID · d3e4b349-6860-44ce-bc59-4aef0d6237ae
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 697936
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
15- 21 CFR 211.100(b)Procedure Deviations Recorded and Justified
- 21 CFR 211.25(a)Training--operations, GMPs, written procedures
- 21 CFR 211.198(a)Complaint Handling Procedure
- 21 CFR 211.113(a)Procedures for non-sterile drug products
- 21 CFR 211.84(d)(2)Reports of Analysis (Components)
- 21 CFR 211.170(b)Reserve samples identified, representative, stored
- 21 CFR 211.68(a)Calibration/Inspection/Checking not done
- 21 CFR 211.125(a)Strict control not exercised over labeling issued
- 21 CFR 211.22(a)Lack of quality control unit
- 21 CFR 211.166(a)Lack of written stability program
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Other FDA inspections of Whitney Labs LP
3| Date | Classification | Office | Project area |
|---|---|---|---|
| March 31, 2015 | OAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| July 10, 2013 | OAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| January 26, 2012 | OAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
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