FDA Inspection
BENEV Company IncBENEV Company Inc – FDA Inspection, Dec 14, 2010
Record Details
This FDA Inspection record concerns BENEV Company Inc, with an inspection on December 14, 2010, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- BENEV Company Inc
- Inspection Date
- December 14, 2010
- Product Type
- Drugs
View Company Profile
ID · d3225606-7c64-478a-9232-8da1a2a74c3b
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 703135
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
18- 21 CFR 211.122(d)Label storage access limited to authorized personnel
- 21 CFR 211.188(b)(8)Labeling control records including specimens or copies
- 21 CFR 211.48(b)Drains--Size, Back-siphonage Prevention
- 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 211.63Equipment Design, Size and Location
- 21 CFR 211.84(e)Rejecting When Specifications Not Met
- 21 CFR 211.194(a)(4)Complete Test Data
- 21 CFR 211.84(d)(2)Reports of Analysis (Components)
Showing 10 of 18 citations.
Full citation text and observation details available on the Dashboard.
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 |
| September 30, 2009 | 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 616277 - 2009-09-30
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.