FDA Inspection 1089903 — Sanit Technologies, LLC dba Durisan
The FDA completed an inspection of Sanit Technologies, LLC dba Durisan on May 17, 2019 in Sarasota, FL. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 9 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- May 17, 2019
- Fiscal Year
- 2019
- Product Type
- Drugs
- Project Area
- Over-the-Counter Drug Evaluation
- Location
- Sarasota, FL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1111 | 21 CFR 211.25(a) | Training , Education , Experience overall |
| 1215 | 21 CFR 211.67(b) | Written procedures not established/followed |
| 1227 | 21 CFR 211.67(c) | Cleaning/maintenance records not kept |
| 1883 | 21 CFR 211.165(a) | Testing and release for distribution |
| 1914 | 21 CFR 211.166(a) | Lack of written stability program |
| 2012 | 21 CFR 211.188(b) | Batch production and Batch Control Record Requirements |
| 3603 | 21 CFR 211.160(b) | Scientifically sound laboratory controls |
| 4355 | 21 CFR 211.165(c) | Sampling and testing plans not followed |
| 9001 | 21 CFR 211.22(a) | Lack of quality control unit |