FDA Inspection 1252006 — RC Outsourcing, LLC
The FDA completed an inspection of RC Outsourcing, LLC on Sep 27, 2024 in Lowellville, OH. The inspection was classified OAI (Official Action Indicated — regulatory and/or administrative actions are recommended). 8 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Official Action Indicated (OAI)
- End Date
- Sep 27, 2024
- Fiscal Year
- 2024
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Lowellville, OH (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1358 | 21 CFR 211.100(b) | SOPs not followed / documented |
| 1435 | 21 CFR 211.42(c)(10)(v) | Cleaning System |
| 1451 | 21 CFR 211.113(b) | Procedures for sterile drug products |
| 2027 | 21 CFR 211.192 | Investigations of discrepancies, failures |
| 2420 | 21 CFR 211.198(a) | Quality Control Review |
| 3603 | 21 CFR 211.160(b) | Scientifically sound laboratory controls |
| 3629 | 21 CFR 211.170(b) | Reserve samples identified, representative, stored |
| 4413 | 21 CFR 211.194(a)(8) | Second person sign off |