FDA Inspection
CenexiCenexi – FDA Inspection, Apr 28, 2015
Record Details
This FDA Inspection record concerns Cenexi, with an inspection on April 28, 2015, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Cenexi
- Inspection Date
- April 28, 2015
- Product Type
- Drugs
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ID · c83ecdf6-c321-438b-9ffa-b6960ca958a0
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 924508
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
9- 21 CFR 211.42(c)(10)(v)Cleaning System
- 21 CFR 211.198(a)Complaint Handling Procedure
- 21 CFR 211.113(b)Procedures for sterile drug products
- 21 CFR 211.28(a)Protective Apparel Not Worn
- 21 CFR 211.192Investigations of discrepancies, failures
- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 211.56(b)Written sanitation procedures not followed
- 21 CFR 211.101(a)Batches Formulated to less than 100%
- 21 CFR 211.100(b)SOPs not followed / documented
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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 |
| December 11, 2012 | VAI | 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 811365 - 2012-12-11
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