FDA Inspection
Covis Pharma GmBHCovis Pharma GmBH – FDA Inspection, Jul 15, 2016
Record Details
This FDA Inspection record concerns Covis Pharma GmBH, with an inspection on July 15, 2016, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Covis Pharma GmBH
- Inspection Date
- July 15, 2016
- Product Type
- Drugs
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ID · e03436c5-2531-4b26-94ec-738dabe9dd52
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 981007
- FDA center
- Human Drugs
- Project area
- Bioresearch Monitoring
FDA Citations
3- 21 CFR 314.80(c)(1)(ii)Failure to investigate serious, unexpected events
- 21 CFR 314.80(c)(1)(i)Late submission of 15-day report
- 21 CFR 314.80(b)Failure to develop written procedures
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Other FDA inspections of Covis Pharma GmBH
7| Date | Classification | Office | Project area |
|---|---|---|---|
| September 19, 2024 | NAI | Center for Drug Evaluation and Research | Bioresearch Monitoring |
| April 5, 2019 | NAI | Center for Drug Evaluation and Research | Bioresearch Monitoring |
| October 22, 2018 | NAI | Center for Drug Evaluation and Research | Bioresearch Monitoring |
| July 28, 2014 | NAI | Center for Drug Evaluation and Research | Bioresearch Monitoring |
| May 21, 2014 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Covis Pharma GmBH
- FDA Inspection 1250807 - 2024-09-19
- FDA Inspection 1087302 - 2019-04-05
- FDA Inspection 1071326 - 2018-10-22
- FDA Inspection 892953 - 2014-07-28
- FDA Inspection 878312 - 2014-05-21
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