FDA Inspection
Spire Biomedical, Inc.Spire Biomedical, Inc. – FDA Inspection, Nov 2, 2009
Record Details
This FDA Inspection record concerns Spire Biomedical, Inc., with an inspection on November 2, 2009, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Spire Biomedical, Inc.
- Inspection Date
- November 2, 2009
- Product Type
- Devices
View Company Profile
ID · e334bc1f-a885-4547-9426-7386d514ff72
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 626332
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
2- 21 CFR 820.75(b)Lack/Inad procedure-Monitoring/Control of Validated Proces
- 21 CFR 820.50(b)Approval, inadequate purchasing data
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