FDA Inspection 953897 — RemedyRePack Inc.
The FDA completed an inspection of RemedyRePack Inc. on November 23, 2015 in Indiana, PA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 10 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- November 23, 2015
- Fiscal Year
- 2016
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Indiana, PA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1136 | 21 CFR 211.25(c) | Inadequate number of personnel |
| 1274 | 21 CFR 211.68(a) | Calibration/Inspection/Checking not done |
| 1448 | 21 CFR 211.111 | Establishment of time limitations |
| 1550 | 21 CFR 211.125(f) | Procedures Written and Followed |
| 1626 | 21 CFR 211.130 | Procedures are written, and followed |
| 2008 | 21 CFR 211.186(a) | Written procedures followed |
| 2419 | 21 CFR 211.198(a) | Complaint Handling Procedure |
| 4304 | 21 CFR 211.68(b) | Written record not kept of program and validation data |
| 4359 | 21 CFR 211.170(b)(1) | Retention time of reserve samples, in general |
| 4576 | 21 CFR 211.192 | No written record of investigation |