FDA Inspection 725683 — D.O.R.C. Dutch Opthalmic Research Center Intl B.V.
The FDA completed an inspection of D.O.R.C. Dutch Opthalmic Research Center Intl B.V. on Apr 29, 2011 in Zuidland. 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
- Apr 29, 2011
- Fiscal Year
- 2011
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Zuidland (Netherlands)
Citations
| ID | CFR | Description |
|---|---|---|
| 14710 | 21 CFR 820.150 | Lack of or inadequate procedures for storage. |
| 3235 | 21 CFR 820.72(a) | Equipment control activity documentation |