FDA Inspection 760541 — Rohtstein Corp.
The FDA completed an inspection of Rohtstein Corp. on Dec 22, 2011 in Woburn, MA. 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). 6 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Dec 22, 2011
- Fiscal Year
- 2012
- Product Type
- Food/Cosmetics
- Project Area
- Foodborne Biological Hazards
- Location
- Woburn, MA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1067 | 21 CFR 110.40(c) | Non food-contact equipment in processing area |
| 1173 | 21 CFR 110.40(f) | Q.C. instrument accuracy, maintenance |
| 1422 | 21 CFR 110.20(b)(4) | Floors, walls and ceilings |
| 1562 | 21 CFR 110.35(d) | Failure to clean - general |
| 3085 | 21 CFR 114.100(a) | Raw materials, packaging, finished product |
| 4465 | 21 CFR 114.100(c) | Process deviations - action to rectify |