Vetter Pharma Fertigung GmbH & Co. KGJanuary 9, 2017

FDA 483 - Vetter Pharma Fertigung GmbH & Co. KG - January 09, 2017

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Record Details

Vetter Pharma Fertigung Gmbh & Co. KG. in Ravensburg, Germany, a sterile drug manufacturer, was cited for significant deficiencies during an FDA inspection. Observations included incomplete complaint investigations, non-standardized sampling procedures, lack of identity testing for incoming APIs, and inadequate audit trails for computer systems. Additionally, the firm lacked assurance of ISO-5 classification maintenance during sterility testing.

Company: Vetter Pharma Fertigung GmbH & Co. KG
Inspection Date: January 9, 2017
Product Type: Drugs
Office: International Compliance Team
Person: Erika V. Butler (Compliance Officer / Investigator)

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ID · 018e604e-9dc9-4387-a0cc-53b35d09cf36