FDA Inspection 1038027 — Scientech Laboratories Inc
The FDA completed an inspection of Scientech Laboratories Inc on January 19, 2018 in S Plainfield, NJ. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 4 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- January 19, 2018
- Fiscal Year
- 2018
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- S Plainfield, NJ (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1177 | 21 CFR 211.63 | Equipment Design, Size and Location |
| 1810 | 21 CFR 211.160(a) | Lab controls established, including changes |
| 1883 | 21 CFR 211.165(a) | Testing and release for distribution |
| 2031 | 21 CFR 211.194(a) | Complete test data included in records |