FDA Inspection 739999 — Covis Pharma GmBH
The FDA completed an inspection of Covis Pharma GmBH on August 3, 2011 in Waltham, MA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 5 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- August 3, 2011
- Fiscal Year
- 2011
- Product Type
- Drugs
- Project Area
- Bioresearch Monitoring
- Location
- Waltham, MA (United States)
Additional Details
Postmarket Adverse Drug Experience (PADE)
Citations
| ID | CFR | Description |
|---|---|---|
| 2027 | 21 CFR 211.192 | Investigations of discrepancies, failures |
| 4391 | 21 CFR 211.180(e)(2) | Items to cover on annual reviews |
| 6832 | 21 CFR 314.80(c)(2) | Late submission of annual safety reports |
| 8911 | 21 CFR 314.81(b)(1)(ii) | Failure to meet specifications |
| 8912 | 21 CFR 314.81(b)(2) | Timely submission |