FDA Inspection 584043 — RemedyRePack Inc.
The FDA completed an inspection of RemedyRePack Inc. on May 28, 2009 in Indiana, PA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 5 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- May 28, 2009
- Fiscal Year
- 2009
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Indiana, PA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1215 | 21 CFR 211.67(b) | Written procedures not established/followed |
| 1361 | 21 CFR 211.100(a) | Absence of Written Procedures |
| 3570 | 21 CFR 211.100(a) | Approval and review of procedures |
| 4303 | 21 CFR 211.67(b) | Written procedures fail to include |
| 4391 | 21 CFR 211.180(e)(2) | Items to cover on annual reviews |