FDA Inspection 658608 — Pace Analytical Life Sciences
The FDA completed an inspection of Pace Analytical Life Sciences on April 23, 2010 in Salem, NH. The inspection was classified NAI (No Action Indicated — no objectionable conditions were found). 5 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- No Action Indicated (NAI) (NAI)
- End Date
- April 23, 2010
- Fiscal Year
- 2010
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Salem, NH (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1809 | 21 CFR 211.160(a) | Following/documenting laboratory controls |
| 1912 | 21 CFR 211.166(a) | Written program not followed |
| 2032 | 21 CFR 211.194(b) | Test method modification records not maintained |
| 2035 | 21 CFR 211.194(e) | Stability testing records not included |
| 4352 | 21 CFR 211.160(b)(4) | Calibration - at intervals, written program, remedial action |