FDA Inspection
BENEV Company IncBENEV Company Inc – FDA Inspection, Sep 30, 2009
Record Details
This FDA Inspection record concerns BENEV Company Inc, with an inspection on September 30, 2009, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- BENEV Company Inc
- Inspection Date
- September 30, 2009
- Product Type
- Drugs
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ID · bd67d658-10d9-4838-8770-f665390cfb79
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 616277
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
25- 21 CFR 211.180(b)Record maintenance 1 year (except exempt OTC)
- 21 CFR 211.100(a)Changes to Procedures Not Reviewed, Approved
- 21 CFR 211.198(a)Adverse Drug Experience
- 21 CFR 211.192Quality control unit review of records
- 21 CFR 211.25(a)Training--operations, GMPs, written procedures
- 21 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
- 21 CFR 211.65(a)Equipment construction - reactive surfaces
- 21 CFR 211.84(e)Rejecting When Specifications Not Met
- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.194(a)(4)Complete Test Data
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Other FDA inspections of BENEV Company Inc
4| Date | Classification | Office | Project area |
|---|---|---|---|
| July 18, 2016 | VAI | Center for Food Safety and Applied Nutrition | Colors and Cosmetics Technology |
| April 20, 2016 | NAI | Center for Food Safety and Applied Nutrition | Colors and Cosmetics Technology |
| February 22, 2013 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| December 14, 2010 | OAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for BENEV Company Inc
- FDA Inspection 983610 - 2016-07-18
- FDA Inspection 966867 - 2016-04-20
- FDA Inspection 820049 - 2013-02-22
- FDA Inspection 703135 - 2010-12-14
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