FDA 483 - Biologische Heilmittel Heel Gmbh - February 01, 2019

Biologische Heilmittel Heel Gmbh, a sterile drug manufacturer in Baden-Baden, Germany, was cited for multiple quality control deficiencies during an FDA inspection. The observations highlight issues with product testing, adherence to established procedures, data integrity, and inadequate documentation of manufacturing processes. These findings indicate a need for significant improvements in the firm's quality management system.