762087
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- January 26, 2012
- Fiscal Year
- 2012
- Product Type
- Drugs
- Project Area
- Unapproved and Misbranded Drugs
- Location
- Port Washington, NY (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15641 | 21 CFR 111.453 | Written procedures - holding |
| 15829 | 21 CFR 111.70(b)(1) | Specifications - component identity |
| 15838 | 21 CFR 111.70(d) | Specifications - labels, packaging |
| 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 |
| 15863 | 21 CFR 111.75(a)(2)(ii)(B) | Component - certificate of analysis |
| 15869 | 21 CFR 111.75(c) | Specifications met - verify; finished batch |
| 15927 | 21 CFR 111.103 | Written procedures - quality control operations |
| 15964 | 21 CFR 111.113(c) | Document - material review, disposition |
| 16013 | 21 CFR 111.140(b)(1) | Records - quality control operations; responsibilities |
| 16042 | 21 CFR 111.503 | Written procedures - returned dietary supplement |