FDA Inspection
Medela IncMedela Inc – FDA Inspection, May 25, 2012
Record Details
This FDA Inspection record concerns Medela Inc, with an inspection on May 25, 2012, issued by the Center for Food Safety and Applied Nutrition, covering food/cosmetics.
- Company
- Medela Inc
- Inspection Date
- May 25, 2012
- Product Type
- Food/cosmetics
View Company Profile
ID · 8a16c277-9263-41cb-b9ed-86b653a8c391
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 779907
- FDA center
- Foods & Cosmetics
- Project area
- Foodborne Biological Hazards
FDA Citations
7- 21 CFR 820.30(d)Design output - documentation
- 21 CFR 110.40(a)Food-contact - unlawful indirect additives
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.80(d)Lack of or inadequate final acceptance procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.90(a)Nonconforming product, 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 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 |
| 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 |
| November 1, 2010 | OAI | 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 755250 - 2011-11-21
- FDA Inspection 747437 - 2011-08-09
- FDA Inspection 696530 - 2010-11-01
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