FDA Inspection 951667 — Materne, North America
The FDA completed an inspection of Materne, North America on December 1, 2015 in Grawn, MI. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 16 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- December 1, 2015
- Fiscal Year
- 2016
- Product Type
- Food/Cosmetics
- Project Area
- Foodborne Biological Hazards
- Location
- Grawn, MI (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1571 | 21 CFR 110.35(d)(5) | Shown to be effective |
| 1581 | 21 CFR 110.37(e) | Running water at suitable temperature |
| 1598 | 21 CFR 110.37(b)(4) | Drainage |
| 1601 | 21 CFR 110.37(a) | Safe and adequate sanitary quality |
| 1669 | 21 CFR 110.80(a)(3) | Aflatoxin and other natural toxins |
| 1709 | 21 CFR 110.80(b)(13) | Filling, assembling, packing controls |
| 1763 | 21 CFR 110.35(b)(1) | Safe and adequate for use |
| 2386 | 21 CFR 110.80(a)(1) | Storage |
| 2387 | 21 CFR 110.80(a)(1) | Washing and cleaning |
| 2393 | 21 CFR 110.80(b)(1) | Teardown equipment/thorough cleaning |
| 3062 | 21 CFR 114.10 | Personnel |
| 3072 | 21 CFR 114.80(a)(1) | Thermal processing |
| 3647 | 21 CFR 110.10(c) | Training of handlers and supervisors |
| 3660 | 21 CFR 110.37(e)(4) | Devices and fixtures |
| 4470 | 21 CFR 108.25(c)(2) | Process filing |
| 990 | 21 CFR 110.10(b)(3) | Not washed/sanitized when appropriate |