FDA Inspection
OPKO Diagnostics, LLCOPKO Diagnostics, LLC – FDA Inspection, Dec 11, 2018
Record Details
This FDA Inspection record concerns OPKO Diagnostics, LLC, with an inspection on December 11, 2018, issued by the New England District Office, covering medical devices & rad health.
- Company
- OPKO Diagnostics, LLC
- Inspection Date
- December 11, 2018
- Product Type
- Medical Devices & Rad Health
View Company Profile
ID · 45216dca-7b50-4f57-8210-53803f9c0f87
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1074293
- FDA center
- Medical Devices & Rad Health
- Project area
- Project Evaluation: Devices
- Outcome
- Form 483 issued
FDA Citations
5- 21 CFR 820.50(a)(3)Acceptable supplier records, inadequate records
- 21 CFR 820.70(c)Environmental control Lack of or inadequate procedures
- 21 CFR 820.70(g)(1)Maintenance schedule, Lack of or inadequate schedule
- 21 CFR 820.75(b)Lack/Inad procedure-Monitoring/Control of Validated Proces
- 21 CFR 820.90(b)(2)Product rework documentation, DHR {see also 820.184}
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Other FDA inspections of OPKO Diagnostics, LLC
2| Date | Classification | Office | Project area |
|---|---|---|---|
| July 1, 2020 | NAI | Center for Devices and Radiological Health | Bioresearch Monitoring |
| January 31, 2018 | NAI | Center for Devices and Radiological Health | Bioresearch Monitoring |
Other documents for OPKO Diagnostics, LLC
- FDA Inspection 1125672 - 2020-07-01
- FDA Inspection 1043590 - 2018-01-31
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