Company
United StatesNuclea Diagnostic Laboratories, LLC., Cambridge, MA – FDA Inspections
Inspection records and compliance data for Nuclea Diagnostic Laboratories, LLC. in Cambridge, Massachusetts. 2 FDA inspections on record, last inspected December 06, 2013.
Company Profile
This profile covers Nuclea Diagnostic Laboratories, LLC. based in Cambridge, Massachusetts, United States.
FDA Inspection History
- FDA inspections
- 2
- OAI
- 0
- VAI
- 2
- NAI
- 0
- Form 483s
- 0
- Warning letters
- 0
First inspected July 9, 2009. Last inspected December 6, 2013.
Most cited issue areas
- Acceptable supplier records, inadequate records1 inspection
- Documentation - review in response to changes or deviations1 inspection
- Nonconforming product control1 inspection
FDA inspections (2)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| December 6, 2013 | VAI | Medical Devices & Rad Health · Compliance: Devices | 858624 |
| July 9, 2009 | VAI | Medical Devices & Rad Health · Compliance: Devices | 596826 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
Nuclea Diagnostic Laboratories, LLC.
FEI Number
1000513165
Address
100 Acorn Park Dr, Cambridge, Massachusetts 02140, United States
Country
United States
ID: bb5844f0-d3d6-46b6-9327-adf7d7f7ceec