Company
United StatesInstrumentation Laboratory, Bedford, MA – FDA Inspections
Inspection records and compliance data for Instrumentation Laboratory in Bedford, Massachusetts. 2 FDA inspections on record, last inspected July 12, 2013.
Company Profile
This profile covers Instrumentation Laboratory based in Bedford, Massachusetts, United States.
FDA Inspection History
- FDA inspections
- 2
- OAI
- 0
- VAI
- 2
- NAI
- 0
- Form 483s
- 0
- Warning letters
- 0
First inspected August 24, 2011. Last inspected July 12, 2013.
Most cited issue areas
- Design Validation - Risk analysis not performed/inadequate1 inspection
- Evaluation of suppliers, contractors, etc., requirements1 inspection
- Lack of or inadequate process validation1 inspection
FDA inspections (2)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| July 12, 2013 | VAI | Medical Devices & Rad Health · Compliance: Devices | 837911 |
| August 24, 2011 | VAI | Medical Devices & Rad Health · Compliance: Devices | 742203 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
Instrumentation Laboratory
FEI Number
1217183
Address
180 Hartwell Rd, Bedford, Massachusetts 01730, United States
Country
United States
ID: 1a0b92a6-867f-4b86-b886-aca56014bb83