Company
United StatesOPKO Diagnostics, LLC, Woburn, MA – FDA Inspections
Inspection records and compliance data for OPKO Diagnostics, LLC in Woburn, Massachusetts. 3 FDA inspections on record, 1 Form 483, last inspected July 01, 2020.
Company Profile
This profile covers OPKO Diagnostics, LLC based in Woburn, Massachusetts, United States.
FDA Inspection History
- FDA inspections
- 3
- OAI
- 0
- VAI
- 1
- NAI
- 2
- Form 483s
- 1
- Warning letters
- 0
First inspected January 31, 2018. Last inspected July 1, 2020.
Most cited issue areas
- Acceptable supplier records, inadequate records1 inspection
- Environmental control Lack of or inadequate procedures1 inspection
- Lack/Inad procedure-Monitoring/Control of Validated Proces1 inspection
FDA inspections (3)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| July 1, 2020 | NAI | Medical Devices & Rad Health · Bioresearch Monitoring | 1125672 |
| December 11, 2018 | VAI | Medical Devices & Rad Health · Project Evaluation: Devices | 1074293 |
| January 31, 2018 | NAI | Medical Devices & Rad Health · Bioresearch Monitoring | 1043590 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
OPKO Diagnostics, LLC
FEI Number
3010909452
Address
4 Constitution Way, Woburn, Massachusetts 01801, United States
Country
United States
ID: 9c960759-0431-4e97-b345-fd6bd51ea1e9