FDA Inspection 764022 — GM Manufacturing Inc.
The FDA completed an inspection of GM Manufacturing Inc. on February 13, 2012 in Gardena, CA. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 12 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- February 13, 2012
- Fiscal Year
- 2012
- Product Type
- Food/Cosmetics
- Project Area
- Food Composition, Standards, Labeling and Econ
- Location
- Gardena, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15404 | 21 CFR 111.12(c) | Personnel - education, training, experience |
| 15442 | 21 CFR 111.15(b)(1) | Physical plant - clean and sanitary |
| 15469 | 21 CFR 111.20(c)(3) | Physical plant - separate areas for products |
| 15532 | 21 CFR 111.255(b) | Batch record - complete |
| 15583 | 21 CFR 111.155(d)(1) | Components - identify lot received |
| 15734 | 21 CFR 111.360 | Manufacturing operations - sanitation |
| 15763 | 21 CFR 111.205(a) | Master manufacturing record - unique formulation |
| 15825 | 21 CFR 111.65 | Quality control - quality, dietary supplement |
| 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 |
| 15870 | 21 CFR 111.75(c)(1) | Specifications met - verify; production, process control |
| 16070 | 21 CFR 111.35(b)(2) | Document-equipment date of use, maintain, clean, sanitize |