FDA Inspection
Medica CorporationMedica Corporation – FDA Inspection, Mar 9, 2011
Record Details
This FDA Inspection record concerns Medica Corporation, with an inspection on March 9, 2011, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Medica Corporation
- Inspection Date
- March 9, 2011
- Product Type
- Devices
View Company Profile
ID · 908d95ba-72c7-4625-94ca-b0e9ea066de7
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 715680
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
5- 21 CFR 820.100(b)Documentation
- 21 CFR 820.80(c)Lack of or inadequate In-process acceptance procedures
- 21 CFR 820.150Lack of or inadequate procedures for storage.
- 21 CFR 820.70(e)Contamination control, Lack of or inadequate procedures
- 21 CFR 820.30(g)Design validation - production units
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Medica Corporation
2| Date | Classification | Office | Project area |
|---|---|---|---|
| April 14, 2017 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| March 15, 2013 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Medica Corporation
- FDA Inspection 1008516 - 2017-04-14
- FDA Inspection 822743 - 2013-03-15
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.