FDA Inspection 721383 — Receptopharm Inc
The FDA completed an inspection of Receptopharm Inc on April 20, 2011 in Plantation, FL. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 6 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- April 20, 2011
- Fiscal Year
- 2011
- Product Type
- Drugs
- Project Area
- Unapproved and Misbranded Drugs
- Location
- Plantation, FL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1049 | 21 CFR 211.22(a) | Approve or reject components, products |
| 1274 | 21 CFR 211.68(a) | Calibration/Inspection/Checking not done |
| 1550 | 21 CFR 211.125(f) | Procedures Written and Followed |
| 1874 | 21 CFR 211.180(b) | Record maintenance 3 years (exempt OTC drugs) |
| 4344 | 21 CFR 211.160(b)(1) | Sampling and testing procedures described |
| 9001 | 21 CFR 211.22(a) | Lack of quality control unit |