FDA Inspection 886830 — Long Island Pharmaceuticals LLC
The FDA completed an inspection of Long Island Pharmaceuticals LLC on July 3, 2014 in Ronkonkoma, 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 3, 2014
- Fiscal Year
- 2014
- Product Type
- Food/Cosmetics
- Project Area
- Food Composition, Standards, Labeling and Econ
- Location
- Ronkonkoma, NY (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15442 | 21 CFR 111.15(b)(1) | Physical plant - clean and sanitary |
| 15511 | 21 CFR 111.27(d) | Equipment - maintain - general |
| 15641 | 21 CFR 111.453 | Written procedures - holding |
| 15662 | 21 CFR 111.303 | Written procedures - laboratory operations |
| 15675 | 21 CFR 111.315(b) | Sampling plans; establish, follow |
| 15797 | 21 CFR 111.553 | Written procedures - product complaint |
| 15858 | 21 CFR 111.75(a)(1)(i) | Component - verify identity, dietary ingredient |
| 15869 | 21 CFR 111.75(c) | Specifications met - verify; finished batch |
| 15927 | 21 CFR 111.103 | Written procedures - quality control operations |
| 15963 | 21 CFR 111.113(b)(2) | Quality control - reject; specification not met |
| 15984 | 21 CFR 111.123(a)(8) | Quality control - finished batch, distribution |