FDA Inspection 582661 — Pace Analytical Life Sciences
The FDA completed an inspection of Pace Analytical Life Sciences on May 14, 2009 in Salem, NH. 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
- May 14, 2009
- Fiscal Year
- 2009
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Salem, NH (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1111 | 21 CFR 211.25(a) | Training , Education , Experience overall |
| 2027 | 21 CFR 211.192 | Investigations of discrepancies, failures |
| 4342 | 21 CFR 211.142(b) | Storage under appropriate conditions |