FDA Inspection 972377 — International Trading Pharm Lab Inc
The FDA completed an inspection of International Trading Pharm Lab Inc on Apr 29, 2016 in Paterson, NJ. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 3 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Apr 29, 2016
- Fiscal Year
- 2016
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Paterson, NJ (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 2031 | 21 CFR 211.194(a) | Complete test data included in records |
| 3613 | 21 CFR 211.160(b)(4) | Establishment of calibration procedures |
| 4406 | 21 CFR 211.194(a)(2) | Suitability of testing methods verified |