FDA Inspection
DARCO International IncDARCO International Inc – FDA Inspection, Jun 16, 2015
Record Details
This FDA Inspection record concerns DARCO International Inc, with an inspection on June 16, 2015, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- DARCO International Inc
- Inspection Date
- June 16, 2015
- Product Type
- Devices
View Company Profile
ID · 51856636-b8de-4d1b-b5c0-e36b7f5a1218
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 930242
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
5- 21 CFR 820.20(c)Management review - defined interval, sufficient frequency
- 21 CFR 820.22Quality audits - Lack of or inadequate procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.25(b)Training - Lack of or inadequate procedures
- 21 CFR 803.17Lack of Written MDR Procedures
Full citation text and observation details available on the Dashboard.
Other FDA inspections of DARCO International Inc
1| Date | Classification | Office | Project area |
|---|---|---|---|
| November 14, 2018 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for DARCO International Inc
- FDA Inspection 1077754 - 2018-11-14
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.