FDA Inspection
SpaceBander CorporationSpaceBander Corporation – FDA Inspection, May 27, 2025
Record Details
This FDA Inspection record concerns SpaceBander Corporation, with an inspection on May 27, 2025, issued by the New Jersey District Office, covering medical devices & rad health.
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ID · c643c619-966b-4981-bbc1-eb7ce90c5854
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1271168
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Medical Devices
FDA Citations
8- DHR - not or inadequately maintained
- Nonconforming product, Lack of or inadequate procedures
- Purchasing controls, Lack of or inadequate procedures
- Evaluation of suppliers, contractors, etc., requirements
- 21 CFR 820.184DHR - not or inadequately maintained
- 21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
- 21 CFR 820.50(a)Evaluation of suppliers, contractors, etc., requirements
- 21 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures
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Other FDA inspections of SpaceBander Corporation
1| Date | Classification | Office | Project area |
|---|---|---|---|
| June 2, 2022 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
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