FDA Inspection 885209 — Hydrox Chemical Company
The FDA completed an inspection of Hydrox Chemical Company on Sep 4, 2014 in Elgin, IL. 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). 9 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Sep 4, 2014
- Fiscal Year
- 2014
- Product Type
- Food/Cosmetics
- Project Area
- Colors and Cosmetics Technology
- Location
- Elgin, IL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1177 | 21 CFR 211.63 | Equipment Design, Size and Location |
| 1213 | 21 CFR 211.67(a) | Cleaning / Sanitizing / Maintenance |
| 1361 | 21 CFR 211.100(a) | Absence of Written Procedures |
| 1395 | 21 CFR 211.103 | Actual vs. theoretical yields not determined |
| 1791 | 21 CFR 211.80(c) | Storage off Floor, Spaced Suitably |
| 1978 | 21 CFR 211.182 | Personnel dating/signing equipment log |
| 3582 | 21 CFR 211.105(a) | Identification of containers, lines, equipment |
| 4402 | 21 CFR 211.192 | Written record of investigation incomplete |