FDA Inspection 822462 — Applied Polymer Systems, Inc. d/b/a APS Pharmaco
The FDA completed an inspection of Applied Polymer Systems, Inc. d/b/a APS Pharmaco on March 14, 2013 in Lindenhurst, 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
- March 14, 2013
- Fiscal Year
- 2013
- Product Type
- Food/Cosmetics
- Project Area
- Foodborne Biological Hazards
- Location
- Lindenhurst, NY (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15450 | 21 CFR 111.15(f)(3) | Plumbing - source of contamination |
| 15499 | 21 CFR 111.27(a) | Equipment - design - suitable |
| 15532 | 21 CFR 111.255(b) | Batch record - complete |
| 15734 | 21 CFR 111.360 | Manufacturing operations - sanitation |
| 15746 | 21 CFR 111.210(h)(1) | Instructions; specifications; quality |
| 15747 | 21 CFR 111.210(g) | Packaging description, representative label |
| 15763 | 21 CFR 111.205(a) | Master manufacturing record - unique formulation |
| 15832 | 21 CFR 111.70(c)(1) | In-process identity, purity, strength, composition |
| 15839 | 21 CFR 111.70(e) | Specifications - identity, purity, strength, composition |
| 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 |