FDA Inspection 959784 — RC Outsourcing, LLC
The FDA completed an inspection of RC Outsourcing, LLC on February 9, 2016 in Lowellville, OH. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 8 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- February 9, 2016
- Fiscal Year
- 2016
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Lowellville, OH (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1169 | 21 CFR 211.42(a) | Buildings of Suitable Size, Construction, Location |
| 1274 | 21 CFR 211.68(a) | Calibration/Inspection/Checking not done |
| 1434 | 21 CFR 211.42(c)(10)(iv) | Environmental Monitoring System |
| 1451 | 21 CFR 211.113(b) | Procedures for sterile drug products |
| 18008 | FDCA 503B(a)(10) | Drug product label, outsourcer facility |
| 1932 | 21 CFR 211.167(a) | Sterility/pyrogen-free testing |
| 2027 | 21 CFR 211.192 | Investigations of discrepancies, failures |
| 3168 | 21 CFR 820.198(a) | Complaints |