FDA Inspection
Whitney Labs LPWhitney Labs LP – FDA Inspection, Mar 31, 2015
Record Details
This FDA Inspection record concerns Whitney Labs LP, with an inspection on March 31, 2015, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Whitney Labs LP
- Inspection Date
- March 31, 2015
- Product Type
- Drugs
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ID · 83480434-1240-4743-b79d-2133676d9a2d
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 920704
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
21- 21 CFR 314.81(b)(1)(ii)Failure to meet specifications
- 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 211.84(d)(2)Testing Each Component for Conformity with Specs
- 21 CFR 211.25(a)Training , Education , Experience overall
- 21 CFR 211.113(a)Procedures for non-sterile drug products
- 21 CFR 211.67(b)(3)Cleaning SOPs/instructions
- 21 CFR 211.184(c)Individual inventory record
Showing 10 of 21 citations.
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Other FDA inspections of Whitney Labs LP
3| Date | Classification | Office | Project area |
|---|---|---|---|
| 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 |
| November 9, 2010 | OAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
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