FDA Inspection 589032 — Provident Pharmaceuticals Llc
The FDA completed an inspection of Provident Pharmaceuticals Llc on Jun 19, 2009 in Colorado Springs, CO. The inspection was classified OAI (Official Action Indicated — regulatory and/or administrative actions are recommended). 11 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Official Action Indicated (OAI)
- End Date
- Jun 19, 2009
- Fiscal Year
- 2009
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Colorado Springs, CO (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1274 | 21 CFR 211.68(a) | Calibration/Inspection/Checking not done |
| 1411 | 21 CFR 211.105(b) | Distinctive ID or code not recorded in batch record |
| 1912 | 21 CFR 211.166(a) | Written program not followed |
| 1943 | 21 CFR 211.180(e)(1) | Review of representative number of batches |
| 2027 | 21 CFR 211.192 | Investigations of discrepancies, failures |
| 3583 | 21 CFR 211.110(a) | Written in-process control procedures |
| 3603 | 21 CFR 211.160(b) | Scientifically sound laboratory controls |
| 3632 | 21 CFR 211.170(b) | Annual visual exams of drug products |
| 4383 | 21 CFR 211.198(b)(1) | Written complaint record must include |
| 4389 | 21 CFR 211.198(a) | Procedures to be written and followed |