Vetter Pharma Fertigung GmbH & Co. KG (Ravensburg Mooswiesen)November 2, 2017

FDA 483 - Vetter Pharma Fertigung GmbH & Co. KG (Ravensburg Mooswiesen) - November 02, 2017

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Record Details

Vetter Pharma-Fertigung GmbH & Co. KG in Ravensburg, Germany, received an FDA Form 483 citing multiple deficiencies during an inspection. Observations included inadequate procedures for preventing microbial contamination of sterile products and a failure to thoroughly review unexplained discrepancies, such as persistent microbial recovery and conflicting cleaning re-qualification results. Additionally, the firm was cited for prematurely releasing starting materials and for not restricting access to labeling storage areas to authorized personnel.

Company: Vetter Pharma Fertigung GmbH & Co. KG (Ravensburg Mooswiesen)
Inspection Date: November 2, 2017
Product Type: Drugs
Office: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
People: Simone E. Pitts (National Expert, Pharmaceutical)
Mihaly S. Ligmond (CSO)

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ID · 2258d7a5-a03c-41c2-802b-a49027241434