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FDA Inspection
•The Midwest Ear Foundation•August 22, 2012

The Midwest Ear Foundation – FDA Inspection, Aug 22, 2012

Record Details

This FDA Inspection record concerns The Midwest Ear Foundation, with an inspection on August 22, 2012, issued by the Center for Biologics Evaluation and Research, covering biologics.

Company
The Midwest Ear Foundation
Inspection Date
August 22, 2012
Product Type
Biologics
Office
Center for Biologics Evaluation and Research
View Company Profile

ID · a78d81c3-8691-49ac-b527-4ac4b327b1b4

Inspection Facts

Voluntary Action Indicated (VAI)

Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.

Inspection number
794539
FDA center
Biologics
Project area
Human Cellular, Tissue, and Gene Therapies

FDA Citations

3
  1. 21 CFR 1271.200(e)Documentation of maintenance and cleaning
  2. 21 CFR 1271.265(f)Return to inventory--procedures
  3. 21 CFR 1271.210(d)(1)Receipt documentation elements

Full citation text and observation details available on the Dashboard.

Other FDA inspections of The Midwest Ear Foundation

1
DateClassificationOfficeProject area
December 9, 2009NAICenter for Biologics Evaluation and ResearchHuman Cellular, Tissue, and Gene Therapies
Other documents for The Midwest Ear Foundation
  • FDA Inspection 633282 - 2009-12-09

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