FDA Inspection
Dutch Ophthalmic USA, Inc.Dutch Ophthalmic USA, Inc. – FDA Inspection, Jun 3, 2011
Record Details
This FDA Inspection record concerns Dutch Ophthalmic USA, Inc., with an inspection on June 3, 2011, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Dutch Ophthalmic USA, Inc.
- Inspection Date
- June 3, 2011
- Product Type
- Devices
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ID · 4b2872ef-64e8-45e5-bdfa-42ee6db1b4d2
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 727303
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
5- 21 CFR 820.198(d)Evaluation, timeliness, identification
- 21 CFR 314.80(c)(2)Failure to report non-alert ADEs
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.25(b)Training - Lack of or inadequate procedures
- 21 CFR 820.20(b)Lack of or inadequate organizational structure
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Other FDA inspections of Dutch Ophthalmic USA, Inc.
1| Date | Classification | Office | Project area |
|---|---|---|---|
| October 24, 2016 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Dutch Ophthalmic USA, Inc.
- FDA Inspection 989790 - 2016-10-24
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