FDA Inspection
Specialty Health Products IncSpecialty Health Products Inc – FDA Inspection, Dec 11, 2025
Record Details
This FDA Inspection record concerns Specialty Health Products Inc, with an inspection on December 11, 2025, issued by the Denver District Office, covering medical devices & rad health.
- Inspection Date
- December 11, 2025
- Product Type
- Medical Devices & Rad Health
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ID · 2ec47953-327a-4af9-8cb3-028b16de16d1
Inspection Facts
- Inspection number
- 1298690
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Medical Devices
- Outcome
- Form 483 issued
FDA Citations
15- 21 CFR 801.20(a)Label to bear a unique device identifier
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.120Lack of or inadequate procedures for labeling
- 21 CFR 820.181DMR - not or inadequately maintained
- 21 CFR 820.184DHR content
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.200(a)Servicing - Lack of or inadequate procedures
- 21 CFR 820.22Quality audits - Lack of or inadequate procedures
- 21 CFR 820.30(g)Design Validation - Risk analysis not performed/inadequate
- 21 CFR 820.30(i)Design changes - Lack of or Inadequate Procedures
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Other FDA inspections of Specialty Health Products Inc
2| Date | Classification | Office | Project area |
|---|---|---|---|
| September 12, 2017 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| December 14, 2011 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Specialty Health Products Inc
- FDA Inspection 1029041 - 2017-09-12
- FDA Inspection 757309 - 2011-12-14
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