FDA Inspection
Jeil Medical CorporationJeil Medical Corporation – FDA Inspection, Jan 23, 2014
Record Details
This FDA Inspection record concerns Jeil Medical Corporation, with an inspection on January 23, 2014, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Jeil Medical Corporation
- Inspection Date
- January 23, 2014
- Product Type
- Devices
View Company Profile
ID · c08ec901-5d5c-40e0-ab11-002b275a1eee
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 865762
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
14- 21 CFR 820.25(b)Training records
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.30(c)Design input - Lack of or inadequate procedures
- 21 CFR 820.30(e)Design review - Lack of or inadequate procedures
- 21 CFR 820.30(f)Design verification - Lack of or inadequate procedures
- 21 CFR 820.250(a)Statistical techniques - Lack of or inadequate procedures
- 21 CFR 820.20(c)Management review - Lack of or inadequate procedures
- 21 CFR 820.22Quality audits - Lack of or inadequate procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.80(c)Lack of or inadequate In-process acceptance procedures
Showing 10 of 14 citations.
Full citation text and observation details available on the Dashboard.
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.