FDA Inspection
Hyphen BioMed sasuHyphen BioMed sasu – FDA Inspection, Jun 20, 2012
Record Details
This FDA Inspection record concerns Hyphen BioMed sasu, with an inspection on June 20, 2012, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Hyphen BioMed sasu
- Inspection Date
- June 20, 2012
- Product Type
- Devices
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ID · 06a810db-f24a-4dce-9a81-2021f73e87ef
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 788357
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
5- 21 CFR 820.40Procedures not adequately established or maintained
- 21 CFR 820.22Quality audits - Lack of or inadequate procedures
- 21 CFR 820.90(b)(2)Product rework procedures, Lack of or inadequate procedures
- 21 CFR 820.72(a)Calibration, Inspection, etc. Procedures Lack of or Inadequ
- 21 CFR 820.184DHR content
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Other FDA inspections of Hyphen BioMed sasu
1| Date | Classification | Office | Project area |
|---|---|---|---|
| February 13, 2014 | OAI | Center for Devices and Radiological Health | Compliance: Devices |
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