FDA Inspection
Qapel Medical Inc.Qapel Medical Inc. – FDA Inspection, Aug 8, 2024
Record Details
This FDA Inspection record concerns Qapel Medical Inc., with an inspection on August 8, 2024, issued by the Center for Devices and Radiological Health, covering devices.
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ID · 1506795c-9c7c-4c54-89ae-9d0064c0769a
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1245810
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
7- 21 CFR 820.30(c)Design input - documentation
- 21 CFR 820.25(b)Training - Lack of or inadequate procedures
- 21 CFR 820.30(f)Design verification - Lack of or inadequate procedures
- 21 CFR 820.50(a)(1)Evaluation and Selection, Suppliers, Contractors, etc.
- 21 CFR 820.40Procedures not adequately established or maintained
- 21 CFR 820.30(i)Design changes - Lack of or Inadequate Procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
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