FDA Inspection 739346 — Piramal Critical Care, Inc.
The FDA completed an inspection of Piramal Critical Care, Inc. on August 12, 2011 in Bethlehem, PA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 2 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- August 12, 2011
- Fiscal Year
- 2011
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Bethlehem, PA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1912 | 21 CFR 211.166(a) | Written program not followed |
| 2419 | 21 CFR 211.198(a) | Complaint Handling Procedure |