FDA Inspection 724041 — RemedyRePack Inc.
The FDA completed an inspection of RemedyRePack Inc. on May 16, 2011 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). 2 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- May 16, 2011
- Fiscal Year
- 2011
- 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 |
| 1358 | 21 CFR 211.100(b) | SOPs not followed / documented |