FDA Inspection 719758 — VWR Advanced Instruments, LLC
The FDA completed an inspection of VWR Advanced Instruments, LLC on April 8, 2011 in Manati, PR. 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
- April 8, 2011
- Fiscal Year
- 2011
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Manati, PR (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 2035 | 21 CFR 211.194(e) | Stability testing records not included |
| 3572 | 21 CFR 211.100(b) | Procedure Deviations Recorded and Justified |