FDA Inspection 1041657 — Mylan Teoranta
The FDA completed an inspection of Mylan Teoranta on Feb 16, 2018 in Inverin. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 2 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Feb 16, 2018
- Fiscal Year
- 2018
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Inverin (Ireland)
Citations
| ID | CFR | Description |
|---|---|---|
| 1136 | 21 CFR 211.25(c) | Inadequate number of personnel |
| 3559 | 21 CFR 211.56(a) | Sanitation--buildings not clean, free of infestation |