FDA Inspection 796480 — Primarch Manufacturing, Inc.
The FDA completed an inspection of Primarch Manufacturing, Inc. on August 24, 2012 in Vista, CA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 17 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- August 24, 2012
- Fiscal Year
- 2012
- 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 |
| 15543 | 21 CFR 111.260(c) | Batch record - date, time; maintenance |
| 15552 | 21 CFR 111.260(j)(2) | Batch record - initials; each step |
| 15554 | 21 CFR 111.260(j)(2)(ii) | Batch record - initials; verifying weight |
| 15560 | 21 CFR 111.260(k)(2) | Batch record - label |
| 15763 | 21 CFR 111.205(a) | Master manufacturing record - unique formulation |
| 15796 | 21 CFR 111.430(b) | Records - packaging, labeling operations |
| 15797 | 21 CFR 111.553 | Written procedures - product complaint |
| 15829 | 21 CFR 111.70(b)(1) | Specifications - component identity |
| 15838 | 21 CFR 111.70(d) | Specifications - labels, packaging |
| 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 |
| 15898 | 21 CFR 111.83(b)(1) | Reserve sample -container-closure system |
| 15928 | 21 CFR 111.103 | Written procedure quality control operations material review |
| 15932 | 21 CFR 111.105(a) | Quality control - processes, specifications, written procedures |
| 16042 | 21 CFR 111.503 | Written procedures - returned dietary supplement |