FDA Inspection
Whitney Labs LPWhitney Labs LP – FDA Inspection, Jul 10, 2013
Record Details
This FDA Inspection record concerns Whitney Labs LP, with an inspection on July 10, 2013, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Whitney Labs LP
- Inspection Date
- July 10, 2013
- Product Type
- Drugs
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ID · 78b0ed62-5df6-47a5-80d8-22755b00e2d3
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 839977
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
17- 21 CFR 211.188Prepared for each batch, include complete information
- 21 CFR 211.100(a)Changes to Procedures Not Reviewed, Approved
- 21 CFR 211.196Distribution Record Requirements
- 21 CFR 211.192Quality control unit review of records
- 21 CFR 211.142(b)Storage under appropriate conditions
- 21 CFR 211.25(a)Training , Education , Experience overall
- 21 CFR 211.28(a)Protective Apparel Not Worn
- 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
Showing 10 of 17 citations.
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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 |
| January 26, 2012 | OAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| November 9, 2010 | OAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
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