FDA Inspection 737714 — Graminex LLC
The FDA completed an inspection of Graminex LLC on August 3, 2011 in Deshler, OH. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 10 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- August 3, 2011
- Fiscal Year
- 2011
- Product Type
- Food/Cosmetics
- Project Area
- Food Composition, Standards, Labeling and Econ
- Location
- Deshler, OH (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15494 | 21 CFR 111.25(c) | Procedures - equipment - cleaning, sanitizing |
| 15665 | 21 CFR 111.303 | Written procedures - tests, examinations; specifications met |
| 15681 | 21 CFR 111.315(d) | Standard reference materials; criteria for selecting |
| 15709 | 21 CFR 111.325(b)(2) | Laboratory methodology followed |
| 15885 | 21 CFR 111.77(a) | Specifications not met - reject, quality control |
| 15928 | 21 CFR 111.103 | Written procedure quality control operations material review |
| 15935 | 21 CFR 111.105(d) | Quality control - basis; tests, examinations |
| 16011 | 21 CFR 111.140(a) | Records - quality control operations: electronic |
| 16020 | 21 CFR 111.140 (b)(3)(ii) | Material review, disposition, follow-up; investigation |
| 16040 | 21 CFR 111.610(a) | Records - available; FDA |