FDA Inspection 1266881 — RemedyRePack Inc.
The FDA completed an inspection of RemedyRePack Inc. on April 14, 2025 in Indiana, PA. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 7 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- April 14, 2025
- Fiscal Year
- 2025
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Indiana, PA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1213 | 21 CFR 211.67(a) | Cleaning / Sanitizing / Maintenance |
| 1361 | 21 CFR 211.100(a) | Absence of Written Procedures |
| 1637 | 21 CFR 211.130(e) | Packaging line inspection after use |
| 2020 | 21 CFR 211.188(b)(8) | Labeling Control Records and Label Copies |
| 4342 | 21 CFR 211.142(b) | Storage under appropriate conditions |
| 4391 | 21 CFR 211.180(e)(2) | Items to cover on annual reviews |