FDA Inspection
Medgyn Products, Inc.Medgyn Products, Inc. – FDA Inspection, Sep 6, 2012
Record Details
This FDA Inspection record concerns Medgyn Products, Inc., with an inspection on September 6, 2012, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Medgyn Products, Inc.
- Inspection Date
- September 6, 2012
- Product Type
- Devices
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ID · e53fb0dc-67b1-4056-acec-9139ea8ca7ac
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 797536
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
12- 21 CFR 820.198(c)Investigation of device failures
- 21 CFR 820.25(a)Personnel
- 21 CFR 820.250(a)Statistical techniques - Lack of or inadequate procedures
- 21 CFR 820.22Quality Audits - defined intervals
- 21 CFR 820.22Quality audit - audit report review
- 21 CFR 820.200(b)Analyzing service report
- 21 CFR 820.22Quality Audit/Reaudit - documentation
- 21 CFR 820.30(j)Design history file
- 21 CFR 820.30(f)Design verification - documentation
- 21 CFR 820.30(g)Design validation - production units
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Other FDA inspections of Medgyn Products, Inc.
2| Date | Classification | Office | Project area |
|---|---|---|---|
| January 18, 2018 | Not classified | Chicago District Office | |
| October 15, 2014 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
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