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FDA Inspection
•Almo-Erzeugnisse Erwin Busch GmbH•March 12, 2015

Almo-Erzeugnisse Erwin Busch GmbH – FDA Inspection, Mar 12, 2015

Record Details

This FDA Inspection record concerns Almo-Erzeugnisse Erwin Busch GmbH, with an inspection on March 12, 2015, issued by the Center for Devices and Radiological Health, covering devices.

Company
Almo-Erzeugnisse Erwin Busch GmbH
Inspection Date
March 12, 2015
Product Type
Devices
Office
Center for Devices and Radiological Health
View Company Profile

ID · 27a2f5a5-da46-4d63-8bd1-318ccf09ddaa

Inspection Facts

Voluntary Action Indicated (VAI)

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

Inspection number
922854
FDA center
Medical Devices & Rad Health
Project area
Compliance: Devices

FDA Citations

3
  1. 21 CFR 820.75(c)Process changes - review, evaluation and revalidation
  2. 21 CFR 820.90(b)(1)Procedures for product review,disposition lack of/inadequate
  3. 21 CFR 820.90(a)Nonconforming product control

Full citation text and observation details available on the Dashboard.

Other FDA inspections of Almo-Erzeugnisse Erwin Busch GmbH

1
DateClassificationOfficeProject area
April 12, 2018Not classifiedOffice of Inspections and InvestigationsCompliance: Devices
Other documents for Almo-Erzeugnisse Erwin Busch GmbH
  • FDA Inspection 1050299 - 2018-04-12

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