FDA Inspection
CenexiCenexi – FDA Inspection, Dec 21, 2018
Record Details
This FDA Inspection record concerns Cenexi, with an inspection on December 21, 2018, issued by the Office of Inspections and Investigations, covering human drugs.
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ID · 33f0f9bf-f9ea-4771-abd1-03c908a0cf7e
Inspection Facts
- Inspection number
- 1075210
- FDA center
- Human Drugs
- Project area
- Generic Drug Evaluation
- Outcome
- Form 483 issued
FDA Citations
8- 21 CFR 211.113(b)Procedures for sterile drug products
- 21 CFR 211.113(b)Validation lacking for sterile drug products
- 21 CFR 211.170(b)Annual visual exams of drug products
- 21 CFR 211.192No written record of investigation
- 21 CFR 211.42(c)(10)(iv)Environmental Monitoring System
- 21 CFR 211.42(c)(10)(v)Cleaning System
- 21 CFR 211.63Equipment Design, Size and Location
- 21 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
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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 |
| 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 |
| 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 1116659 - 2018-06-19
- FDA Inspection 976108 - 2016-04-06
- FDA Inspection 924508 - 2015-04-28
- FDA Inspection 811365 - 2012-12-11
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