FDA Inspection
Covis Pharma GmBHCovis Pharma GmBH – FDA Inspection, Aug 3, 2011
Record Details
This FDA Inspection record concerns Covis Pharma GmBH, with an inspection on August 3, 2011, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Covis Pharma GmBH
- Inspection Date
- August 3, 2011
- Product Type
- Drugs
View Company Profile
ID · 8facc160-fa41-4d42-8777-7b6a29f48609
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 739999
- FDA center
- Human Drugs
- Project area
- Bioresearch Monitoring
FDA Citations
5- 21 CFR 314.81(b)(2)Timely submission
- 21 CFR 314.81(b)(1)(ii)Failure to meet specifications
- 21 CFR 314.80(c)(2)Late submission of annual safety reports
- 21 CFR 211.192Investigations of discrepancies, failures
- 21 CFR 211.180(e)(2)Items to cover on annual reviews
Full citation text and observation details available on the Dashboard.
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 15, 2016 | VAI | Center for Drug Evaluation and Research | Bioresearch Monitoring |
| July 28, 2014 | NAI | Center for Drug Evaluation and Research | Bioresearch Monitoring |
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 981007 - 2016-07-15
- FDA Inspection 892953 - 2014-07-28
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.