FDA Inspection 1045988 — Cantrell Drug Company
The FDA completed an inspection of Cantrell Drug Company on March 22, 2018 in Little Rock, AR. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 4 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- March 22, 2018
- Fiscal Year
- 2018
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Little Rock, AR (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1451 | 21 CFR 211.113(b) | Procedures for sterile drug products |
| 1843 | 21 CFR 211.84(d)(2) | Component written specification |
| 2028 | 21 CFR 211.192 | Extent of discrepancy, failure investigations |
| 2567 | 21 CFR 211.198(a) | Adverse Drug Experience |