FDA Inspection
OphthalMed LLCOphthalMed LLC – FDA Inspection, May 1, 2017
Record Details
This FDA Inspection record concerns OphthalMed LLC, with an inspection on May 1, 2017, issued by the Center for Devices and Radiological Health, covering devices.
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ID · 774593e4-8a31-4a55-a347-9ab2282c2463
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1020101
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
8- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.184DHR - not or inadequately maintained
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.25(b)Training records
- 21 CFR 820.40Lack of procedures, or not maintained
- 21 CFR 820.40(a)Document locations, Dissemination, etc.
- 21 CFR 820.80(b)Lack of or inadequate receiving acceptance procedures
- 21 CFR 820.90(b)(2)Product rework documentation, DHR {see also 820.184}
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Other FDA inspections of OphthalMed LLC
2| Date | Classification | Office | Project area |
|---|---|---|---|
| February 24, 2014 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| August 2, 2011 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for OphthalMed LLC
- FDA Inspection 868674 - 2014-02-24
- FDA Inspection 739449 - 2011-08-02
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