Company
United StatesSpire Biomedical, Inc., Bedford, MA – FDA Inspections
Inspection records and compliance data for Spire Biomedical, Inc. in Bedford, Massachusetts. 1 FDA inspection on record, last inspected November 02, 2009.
Company Profile
This profile covers Spire Biomedical, Inc. based in Bedford, Massachusetts, United States.
FDA Inspection History
- FDA inspections
- 1
- OAI
- 0
- VAI
- 1
- NAI
- 0
- Form 483s
- 0
- Warning letters
- 0
Inspected November 2, 2009.
Most cited issue areas
- Approval, inadequate purchasing data1 inspection
- Lack/Inad procedure-Monitoring/Control of Validated Proces1 inspection
FDA inspections (1)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| November 2, 2009 | VAI | Medical Devices & Rad Health · Compliance: Devices | 626332 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
Spire Biomedical, Inc.
FEI Number
1000159376
Address
1 Patriots Park, Bedford, Massachusetts 01730, United States
Country
United States
ID: f1455a99-1fdc-4126-a59b-12818cb34a65