877283
PreMark Health Science, Inc. — FEI 3006709710
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- April 24, 2014
- Fiscal Year
- 2014
- Product Type
- Food/Cosmetics
- Project Area
- Food Composition, Standards, Labeling and Econ
- Location
- Irving, TX (United States)
Citations
| ID | CFR | Description |
|---|
| 15532 | 21 CFR 111.255(b) | Batch record - complete |
| 15591 | 21 CFR 111.160(c)(1) | Labels - quarantine; samples |
| 15606 | 21 CFR 111.165(c)(1) | Product received - quarantine; representative samples |
| 15675 | 21 CFR 111.315(b) | Sampling plans; establish, follow |
| 15681 | 21 CFR 111.315(d) | Standard reference materials; criteria for selecting |
| 15763 | 21 CFR 111.205(a) | Master manufacturing record - unique formulation |
| 15829 | 21 CFR 111.70(b)(1) | Specifications - component identity |
| 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 |
| 16066 | 21 CFR 111.35(b)(1)(i) | Written procedures - instruments, controls; calibrating |
| 16070 | 21 CFR 111.35(b)(2) | Document-equipment date of use, maintain, clean, sanitize |
| 1695 | 21 CFR 110.80(b)(2) | Manufacturing conditions |