FDA Inspection 821728 — DS REP B.V. LLC
The FDA completed an inspection of DS REP B.V. LLC on Mar 6, 2013 in Las Piedras, PR. 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). 2 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Mar 6, 2013
- Fiscal Year
- 2013
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Las Piedras, PR (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3172 | 21 CFR 820.198(c) | Investigation of device failures |
| 539 | 21 CFR 820.70(b) | Production and Process Change Procedures, lack of or Inad. |