FDA Inspection 898185 — Spa Technologies International Inc
The FDA completed an inspection of Spa Technologies International Inc on October 3, 2014 in Congers, NY. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 10 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- October 3, 2014
- Fiscal Year
- 2015
- Product Type
- Food/Cosmetics
- Project Area
- Colors and Cosmetics Technology
- Location
- Congers, NY (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1163 | 21 CFR 211.28(b) | Habits of good sanitation & health |
| 1169 | 21 CFR 211.42(a) | Buildings of Suitable Size, Construction, Location |
| 1552 | 21 CFR 110.35(a) | Buildings/sanitary |
| 1632 | 21 CFR 211.130(c) | Lot or control number assigned |
| 1790 | 21 CFR 211.80(b) | Handling and Storage to Prevent Contamination |
| 1883 | 21 CFR 211.165(a) | Testing and release for distribution |
| 1885 | 21 CFR 211.165(b) | Microbiological testing |
| 3547 | 21 CFR 211.46(b) | Equipment for Environmental Control |
| 9001 | 21 CFR 211.22(a) | Lack of quality control unit |