FDA Inspection
Darden CO.Darden CO. – FDA Inspection, Apr 5, 2010
Record Details
This FDA Inspection record concerns Darden CO., with an inspection on April 5, 2010, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Darden CO.
- Inspection Date
- April 5, 2010
- Product Type
- Devices
View Company Profile
ID · 5dfe8056-1648-42ef-8748-8bb2934c5bb1
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 655058
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
4- 21 CFR 820.198(a)General
- 21 CFR 820.22Quality audits - Lack of or inadequate procedures
- 21 CFR 820.20(e)Quality System Procedures
- 21 CFR 803.17Lack of Written MDR Procedures
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.