FDA Inspection
Ben Venue Laboratories IncBen Venue Laboratories Inc – FDA Inspection, Sep 17, 2009
Record Details
This FDA Inspection record concerns Ben Venue Laboratories Inc, with an inspection on September 17, 2009, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Ben Venue Laboratories Inc
- Inspection Date
- September 17, 2009
- Product Type
- Drugs
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ID · d230cb4d-54da-4342-9755-477b2784d110
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 609844
- FDA center
- Human Drugs
- Project area
- Bioresearch Monitoring
FDA Citations
11- 21 CFR 211.188(b)(1)Dates not included for each significant step
- 21 CFR 211.25(a)Training , Education , Experience overall
- 21 CFR 211.46(b)Equipment for Environmental Control
- 21 CFR 211.63Equipment Design, Size and Location
- 21 CFR 211.67(c)Cleaning/maintenance records not kept
- 21 CFR 211.68(a)Calibration/Inspection/Checking not done
- 21 CFR 211.182Chronological Order of Equipment Log Entries
- 21 CFR 211.192Investigations of discrepancies, failures
- 21 CFR 211.67(b)Written procedures fail to include
- 21 CFR 211.100(b)SOPs not followed / documented
Showing 10 of 11 citations.
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Other FDA inspections of Ben Venue Laboratories Inc
9| Date | Classification | Office | Project area |
|---|---|---|---|
| June 6, 2014 | OAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| March 29, 2013 | OAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| December 2, 2011 | OAI | Center for Veterinary Medicine | Monitoring of Marketed Animal Drugs, Feed, and Devices |
| May 25, 2011 | OAI | Center for Veterinary Medicine | Monitoring of Marketed Animal Drugs, Feed, and Devices |
| March 11, 2011 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Ben Venue Laboratories Inc
- FDA Inspection 882591 - 2014-06-06
- FDA Inspection 826465 - 2013-03-29
- FDA Inspection 759506 - 2011-12-02
- FDA Inspection 729039 - 2011-05-25
- FDA Inspection 714969 - 2011-03-11
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