FDA Inspection 969188 — Alliance Technologies, LLC
The FDA completed an inspection of Alliance Technologies, LLC on April 5, 2016 in Monmouth Junction, NJ. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 5 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- April 5, 2016
- Fiscal Year
- 2016
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Monmouth Junction, NJ (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1263 | 21 CFR 211.68(b) | Computer control of master formula records |
| 1890 | 21 CFR 211.165(e) | Test methods |
| 4352 | 21 CFR 211.160(b)(4) | Calibration - at intervals, written program, remedial action |
| 4409 | 21 CFR 211.194(a)(4) | Data secured in course of each test |
| 4576 | 21 CFR 211.192 | No written record of investigation |