FDA Inspection
Blenheim Pharmacal, Inc.Blenheim Pharmacal, Inc. – FDA Inspection, Jun 1, 2010
Record Details
This FDA Inspection record concerns Blenheim Pharmacal, Inc., with an inspection on June 1, 2010, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Blenheim Pharmacal, Inc.
- Inspection Date
- June 1, 2010
- Product Type
- Drugs
View Company Profile
ID · cbecb255-12b5-4bcd-8f6e-a24e9b5f67c6
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 664622
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
2- 21 CFR 211.48(a)Potable water standards not met
- 21 CFR 211.100(b)SOPs not followed / documented
Full citation text and observation details available on the Dashboard.
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 |
| June 19, 2013 | VAI | 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 |
Other documents for Blenheim Pharmacal, Inc.
- FDA Inspection 972339 - 2016-04-29
- FDA Inspection 835574 - 2013-06-19
- FDA Inspection 783890 - 2012-05-18
- FDA Inspection 730684 - 2011-06-17
- FDA Inspection 674345 - 2010-07-28
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.