FDA Inspection 751924 — Kabco Pharmaceuticals, Inc.
The FDA completed an inspection of Kabco Pharmaceuticals, Inc. on October 21, 2011 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
- October 21, 2011
- Fiscal Year
- 2012
- Product Type
- Food/Cosmetics
- Project Area
- Food Composition, Standards, Labeling and Econ
- Location
- Amityville, NY (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15442 | 21 CFR 111.15(b)(1) | Physical plant - clean and sanitary |
| 15494 | 21 CFR 111.25(c) | Procedures - equipment - cleaning, sanitizing |
| 15496 | 21 CFR 111.27(b) | Instruments - calibration |
| 15570 | 21 CFR 111.153 | Written procedures - components |
| 15702 | 21 CFR 111.320(b) | Examination, testing; scientifically valid |
| 15723 | 21 CFR 111.365(i) | Metal, foreign material |
| 15762 | 21 CFR 111.205(a) | Master manufacturing record - each batch |
| 15797 | 21 CFR 111.553 | Written procedures - product complaint |
| 15886 | 21 CFR 111.77(b) | Specifications not met - identity; component, reject |
| 15976 | 21 CFR 111.123 | Quality control operations - master, batch, manufacturing |
| 15986 | 21 CFR 111.123(b)(2) | Quality control - batch, product specifications |