FDA Inspection 669236 — Schwabe North America, Inc.
The FDA completed an inspection of Schwabe North America, Inc. on Jul 9, 2010 in Lehi, UT. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 7 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Jul 9, 2010
- Fiscal Year
- 2010
- Product Type
- Food/Cosmetics
- Project Area
- Food Composition, Standards, Labeling and Econ
- Location
- Lehi, UT (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15434 | 21 CFR 111.15(d)(2) | Pest control measures |
| 15641 | 21 CFR 111.453 | Written procedures - holding |
| 15723 | 21 CFR 111.365(i) | Metal, foreign material |
| 15736 | 21 CFR 111.353 | Manufacturing operations - written procedures |
| 15748 | 21 CFR 111.210(f) | Master manufacturing record theoretical and expected yield |
| 15927 | 21 CFR 111.103 | Written procedures - quality control operations |
| 16083 | 21 CFR 111.35(b)(6) | Documentation - equipment functions; intended use |