FDA Inspection 655743 — Kanec Usa, Inc.
The FDA completed an inspection of Kanec Usa, Inc. on April 19, 2010 in Miramar, FL. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 12 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- April 19, 2010
- Fiscal Year
- 2010
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Miramar, FL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1086 | 21 CFR 211.22(b) | Adequate lab facilities not available |
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 2009 | 21 CFR 211.188 | Prepared for each batch, include complete information |
| 2302 | 21 CFR 820.20(e) | Quality System Procedures |
| 2386 | 21 CFR 110.80(a)(1) | Storage |
| 3125 | 21 CFR 820.80(d) | Lack of or inadequate final acceptance procedures |
| 3160 | 21 CFR 820.184 | Lack of or inadequate DHR procedures |
| 3585 | 21 CFR 211.110(a) | Control procedures to monitor and validate performance |
| 4060 | 21 CFR 820.20(b)(3)(i) | Management representative implementing the quality system |
| 537 | 21 CFR 820.70(a) | Production processes |
| 546 | 21 CFR 820.75(a) | Lack of or inadequate process validation |
| 9001 | 21 CFR 211.22(a) | Lack of quality control unit |