FDA Inspection 1017863 — LEESAR, INC
The FDA completed an inspection of LEESAR, INC on July 12, 2017 in Fort Myers, FL. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 5 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- July 12, 2017
- Fiscal Year
- 2017
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Fort Myers, FL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1435 | 21 CFR 211.42(c)(10)(v) | Cleaning System |
| 1436 | 21 CFR 211.42(c)(10)(vi) | Equipment to control conditions |
| 1451 | 21 CFR 211.113(b) | Procedures for sterile drug products |
| 1810 | 21 CFR 211.160(a) | Lab controls established, including changes |
| 2027 | 21 CFR 211.192 | Investigations of discrepancies, failures |