FDA Inspection
Cardio Technics S.A. de C.V.Cardio Technics S.A. de C.V. – FDA Inspection, Jun 7, 2018
Record Details
This FDA Inspection record concerns Cardio Technics S.A. de C.V., with an inspection on June 7, 2018, issued by the Office of Inspections and Investigations, covering medical devices & rad health.
- Company
- Cardio Technics S.A. de C.V.
- Inspection Date
- June 7, 2018
- Product Type
- Medical Devices & Rad Health
View Company Profile
ID · 669237a9-0078-42a6-8a90-41eec003e20f
Inspection Facts
- Inspection number
- 1056953
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
6- 21 CFR 803.17Lack of Written MDR Procedures
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.20(b)Lack of or inadequate organizational structure
- 21 CFR 820.22Quality audits - Lack of or inadequate procedures
- 21 CFR 820.75(a)Lack of or inadequate process validation
- 21 CFR 820.75(b)Lack/Inad procedure-Monitoring/Control of Validated Proces
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.