# OPKO Diagnostics, LLC – FDA Inspection, Dec 11, 2018

Source: https://www.keypedia.com/records/fda_inspections/opko-diagnostics-llc/45216dca-7b50-4f57-8210-53803f9c0f87
Source feed: FDA_Inspections

> FDA inspection 1074293 of OPKO Diagnostics, LLC, December 11, 2018. Classification: Voluntary Action Indicated (VAI). 5 citations under 21 CFR part 820. Form 483 issued. 2 other FDA inspections on record for this company.

---

## Details

- Record Type: FDA Inspection
- Inspection ID: 1074293
- Company Name: OPKO Diagnostics, LLC
- Inspection Date: 2018-12-11
- Classification: Voluntary Action Indicated (VAI)
- Classification Code: VAI
- Project Area: Project Evaluation: Devices
- Product Type: Medical Devices & Rad Health
- Center: Medical Devices & Rad Health
- Office Name: New England District Office
- Citation Count: 5

## Related Documents

- FDA Inspection 1125672 - 2020-07-01
- FDA Inspection 1043590 - 2018-01-31

## Related Officers

- [Issuing Officer](https://www.keypedia.com/people/sara-m-onyango/643c6ad3-9747-4bc2-9e8e-72f97b11e659)
- [FDA Associated Person](https://www.keypedia.com/people/stephen-c-smith/426649fa-0e5b-4b35-ba41-636512a06a48)

Company: https://www.keypedia.com/companies/opko-diagnostics-llc/9c960759-0431-4e97-b345-fd6bd51ea1e9

Office: https://www.keypedia.com/offices/new-england-district-office/aa458072-2f1d-4231-89f5-21ba7a3b7144