FDA Inspection 1064405 — Aidance Scientific Inc
The FDA completed an inspection of Aidance Scientific Inc on August 31, 2018 in Woonsocket, RI. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 12 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- August 31, 2018
- Fiscal Year
- 2018
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Woonsocket, RI (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1213 | 21 CFR 211.67(a) | Cleaning / Sanitizing / Maintenance |
| 1833 | 21 CFR 211.84(d)(1) | Identity Testing of Each Component |
| 1844 | 21 CFR 211.84(d)(2) | Establish reliability of supplier's C of A |
| 1845 | 21 CFR 211.84(d)(3) | Container/Closure Written Test Procedure |
| 1883 | 21 CFR 211.165(a) | Testing and release for distribution |
| 1885 | 21 CFR 211.165(b) | Microbiological testing |
| 1914 | 21 CFR 211.166(a) | Lack of written stability program |
| 2027 | 21 CFR 211.192 | Investigations of discrepancies, failures |
| 3547 | 21 CFR 211.46(b) | Equipment for Environmental Control |
| 3585 | 21 CFR 211.110(a) | Control procedures to monitor and validate performance |
| 3623 | 21 CFR 211.170(a) | Active ingredient retained sample kept |
| 4391 | 21 CFR 211.180(e)(2) | Items to cover on annual reviews |