FDA Inspection
Blenheim Pharmacal, Inc.Blenheim Pharmacal, Inc. – FDA Inspection, Jun 19, 2013
Record Details
This FDA Inspection record concerns Blenheim Pharmacal, Inc., with an inspection on June 19, 2013, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Blenheim Pharmacal, Inc.
- Inspection Date
- June 19, 2013
- Product Type
- Drugs
View Company Profile
ID · 90fa82d9-9afc-4f87-a105-d91d0ac32a80
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 835574
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
3- 21 CFR 211.142(b)Storage under appropriate conditions
- 21 CFR 211.100(a)Absence of Written Procedures
- 21 CFR 211.100(b)SOPs not followed / documented
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Other FDA inspections of Blenheim Pharmacal, Inc.
6| Date | Classification | Office | Project area |
|---|---|---|---|
| April 29, 2016 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| May 18, 2012 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| June 17, 2011 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| July 28, 2010 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| June 1, 2010 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Blenheim Pharmacal, Inc.
- FDA Inspection 972339 - 2016-04-29
- FDA Inspection 783890 - 2012-05-18
- FDA Inspection 730684 - 2011-06-17
- FDA Inspection 674345 - 2010-07-28
- FDA Inspection 664622 - 2010-06-01
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