FDA Inspection 722529 — Probioferm, LLC
The FDA completed an inspection of Probioferm, LLC on May 5, 2011 in Urbandale, IA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 7 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- May 5, 2011
- Fiscal Year
- 2011
- Product Type
- Food/Cosmetics
- Project Area
- Food Composition, Standards, Labeling and Econ
- Location
- Urbandale, IA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15498 | 21 CFR 111.27(d) | Equipment - maintain, clean, sanitize |
| 15507 | 21 CFR 111.27(a)(5)(i) | Refrigerator, freezer - temperature recording device |
| 15532 | 21 CFR 111.255(b) | Batch record - complete |
| 15581 | 21 CFR 111.155(c)(3) | Quality control - components, approve, release |
| 15868 | 21 CFR 111.75(b)(2) | Specifications met - deviation, unanticipated occurrence |
| 15901 | 21 CFR 111.83(b)(3) | Reserve sample - retained |
| 15932 | 21 CFR 111.105(a) | Quality control - processes, specifications, written procedures |