FDA Inspection 953823 — Temmler Pharma GmbH & Co. KG
The FDA completed an inspection of Temmler Pharma GmbH & Co. KG on December 4, 2015 in Marburg. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 3 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- December 4, 2015
- Fiscal Year
- 2016
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Marburg (Germany)
Citations
| ID | CFR | Description |
|---|---|---|
| 1801 | 21 CFR 211.84(a) | Components withheld from use pending release |
| 1885 | 21 CFR 211.165(b) | Microbiological testing |
| 4364 | 21 CFR 211.176 | Failing to test for penicillin cross-contamination |