FDA Inspection 1046205 — RemedyRePack Inc.
The FDA completed an inspection of RemedyRePack Inc. on Mar 30, 2018 in Indiana, PA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 4 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Mar 30, 2018
- Fiscal Year
- 2018
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Indiana, PA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1393 | 21 CFR 211.103 | Yield calculations not verified by 2nd person |
| 3572 | 21 CFR 211.100(b) | Procedure Deviations Recorded and Justified |
| 3633 | 21 CFR 211.170(b)(1) | Reserve sample retention time |
| 4379 | 21 CFR 211.188(b)(1) | Dates not included for each significant step |