FDA Inspection 828298 — Kabco Pharmaceuticals, Inc.
The FDA completed an inspection of Kabco Pharmaceuticals, Inc. on April 12, 2013 in Amityville, NY. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 8 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- April 12, 2013
- Fiscal Year
- 2013
- Product Type
- Food/Cosmetics
- Project Area
- Food Composition, Standards, Labeling and Econ
- Location
- Amityville, NY (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15747 | 21 CFR 111.210(g) | Packaging description, representative label |
| 15762 | 21 CFR 111.205(a) | Master manufacturing record - each batch |
| 15800 | 21 CFR 111.560(a)(2) | Product complaint - quality control investigate |
| 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 |
| 15869 | 21 CFR 111.75(c) | Specifications met - verify; finished batch |
| 15882 | 21 CFR 111.75(h) | Tests, examinations - scientifically valid |
| 15908 | 21 CFR 111.90(b)(1) | Reprocessed, dietary supplement - no material review |