FDA Inspection
CenexiCenexi – FDA Inspection, Dec 11, 2012
Record Details
This FDA Inspection record concerns Cenexi, with an inspection on December 11, 2012, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Cenexi
- Inspection Date
- December 11, 2012
- Product Type
- Drugs
View Company Profile
ID · a16a6f63-c9ac-46c4-8add-cbde320e2b04
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 811365
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
8- 21 CFR 211.100(a)Changes to Procedures Not Reviewed, Approved
- 21 CFR 211.167(a)Sterility/pyrogen-free testing
- 21 CFR 211.25(a)Training--operations, GMPs, written procedures
- 21 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
- 21 CFR 211.192Extent of discrepancy, failure investigations
- 21 CFR 211.68(a)Written calibration / inspection records not kept
- 21 CFR 211.166(a)(3)Valid stability test methods
- 21 CFR 211.192No written record of investigation
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Other FDA inspections of Cenexi
5| Date | Classification | Office | Project area |
|---|---|---|---|
| October 26, 2022 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| December 21, 2018 | Not classified | Office of Inspections and Investigations | Generic Drug Evaluation |
| June 19, 2018 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| April 6, 2016 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| April 28, 2015 | OAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Cenexi
- FDA Inspection 1245208 - 2022-10-26
- FDA Inspection 1075210 - 2018-12-21
- FDA Inspection 1116659 - 2018-06-19
- FDA Inspection 976108 - 2016-04-06
- FDA Inspection 924508 - 2015-04-28
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