FDA Inspection 849107 — Primarch Manufacturing, Inc.
The FDA completed an inspection of Primarch Manufacturing, Inc. on September 19, 2013 in Vista, CA. The inspection was classified NAI (No Action Indicated — no objectionable conditions were found). 14 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- No Action Indicated (NAI) (NAI)
- End Date
- September 19, 2013
- Fiscal Year
- 2013
- Product Type
- Food/Cosmetics
- Project Area
- Foodborne Biological Hazards
- Location
- Vista, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15525 | 21 CFR 111.30(b) | Equipment - automated - suitability |
| 15532 | 21 CFR 111.255(b) | Batch record - complete |
| 15743 | 21 CFR 111.210(h)(3) | Master manufacturing record - specific actions; quality |
| 15744 | 21 CFR 111.210(h)(2) | Master manufacturing record - sampling, tests, examinations |
| 15745 | 21 CFR 111.210(h)(1) | Instructions; specifications; packaged, labeled |
| 15746 | 21 CFR 111.210(h)(1) | Instructions; specifications; quality |
| 15748 | 21 CFR 111.210(f) | Master manufacturing record theoretical and expected yield |
| 15749 | 21 CFR 111.210(e) | Master manufacturing record - intentional overage |
| 15754 | 21 CFR 111.210(a) | Master manufacturing record - dietary ingredients |
| 15763 | 21 CFR 111.205(a) | Master manufacturing record - unique formulation |
| 15839 | 21 CFR 111.70(e) | Specifications - identity, purity, strength, composition |
| 15840 | 21 CFR 111.70(e) | Specifications - contamination limits |
| 15858 | 21 CFR 111.75(a)(1)(i) | Component - verify identity, dietary ingredient |
| 15932 | 21 CFR 111.105(a) | Quality control - processes, specifications, written procedures |