FDA Inspection 754549 — Quantum Analytics Group Inc.
The FDA completed an inspection of Quantum Analytics Group Inc. on November 14, 2011 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). 6 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- November 14, 2011
- Fiscal Year
- 2012
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Monmouth Junction, NJ (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1111 | 21 CFR 211.25(a) | Training , Education , Experience overall |
| 1177 | 21 CFR 211.63 | Equipment Design, Size and Location |
| 1809 | 21 CFR 211.160(a) | Following/documenting laboratory controls |
| 2031 | 21 CFR 211.194(a) | Complete test data included in records |
| 4352 | 21 CFR 211.160(b)(4) | Calibration - at intervals, written program, remedial action |
| 4406 | 21 CFR 211.194(a)(2) | Suitability of testing methods verified |