FDA Inspection
Medela IncMedela Inc – FDA Inspection, Jan 21, 2010
Record Details
This FDA Inspection record concerns Medela Inc, with an inspection on January 21, 2010, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Medela Inc
- Inspection Date
- January 21, 2010
- Product Type
- Devices
View Company Profile
ID · 24aabd2f-d3a0-4cee-a0fe-9dca9539051b
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 648376
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
7- 21 CFR 803.50(a)(1)Report of Death or Serious Injury
- 21 CFR 820.198(a)(1)Uniform and timely processing
- 21 CFR 820.198(c)Investigation of device failures
- 21 CFR 820.100(a)(1)Analysis of data/reports from data sources
- 21 CFR 820.100(a)(3)Identification of actions needed
- 21 CFR 820.30(i)Design changes - Lack of or Inadequate Procedures
- 21 CFR 820.30(f)Design verification - documentation
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Medela Inc
7| Date | Classification | Office | Project area |
|---|---|---|---|
| August 27, 2014 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| February 26, 2014 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| May 25, 2012 | OAI | Center for Food Safety and Applied Nutrition | Foodborne Biological Hazards |
| November 21, 2011 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| August 9, 2011 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Medela Inc
- FDA Inspection 893426 - 2014-08-27
- FDA Inspection 869654 - 2014-02-26
- FDA Inspection 779907 - 2012-05-25
- FDA Inspection 755250 - 2011-11-21
- FDA Inspection 747437 - 2011-08-09
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.