FDA Inspection 668810 — Kabco Pharmaceuticals, Inc.
The FDA completed an inspection of Kabco Pharmaceuticals, Inc. on July 7, 2010 in Amityville, NY. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 11 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- July 7, 2010
- Fiscal Year
- 2010
- Product Type
- Food/Cosmetics
- Project Area
- Foodborne Biological Hazards
- Location
- Amityville, NY (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15507 | 21 CFR 111.27(a)(5)(i) | Refrigerator, freezer - temperature recording device |
| 15562 | 21 CFR 111.260(l)(1) | Batch record - quality control review; production |
| 15641 | 21 CFR 111.453 | Written procedures - holding |
| 15645 | 21 CFR 111.455(c) | Hold - mix-up, contamination, deterioration |
| 15723 | 21 CFR 111.365(i) | Metal, foreign material |
| 15732 | 21 CFR 111.365(a) | Conditions, controls -protect; microorganisms, contamination |
| 15744 | 21 CFR 111.210(h)(2) | Master manufacturing record - sampling, tests, examinations |
| 15754 | 21 CFR 111.210(a) | Master manufacturing record - dietary ingredients |
| 15858 | 21 CFR 111.75(a)(1)(i) | Component - verify identity, dietary ingredient |
| 15861 | 21 CFR 111.75(a)(2)(ii)(A) | Component - qualify supplier |
| 15951 | 21 CFR 111.110(c) | Quality control operations - tests, examinations; results |