FDA Inspection 820244 — Angiplast Private Limited
The FDA completed an inspection of Angiplast Private Limited on Dec 13, 2012 in Daskroi. 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). 6 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Dec 13, 2012
- Fiscal Year
- 2013
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Daskroi (India)
Citations
| ID | CFR | Description |
|---|---|---|
| 14722 | 21 CFR 820.40 | Procedures not adequately established or maintained |
| 3104 | 21 CFR 820.30(j) | Design history file |
| 3266 | 21 CFR 820.86 | Acceptance status |
| 3375 | 21 CFR 820.198(e) | Records of complaint investigation |
| 3415 | 21 CFR 820.22 | Quality Audit/Reaudit - conducted |
| 3680 | 21 CFR 820.70(a) | Process control procedures, Lack of or inadequate procedures |