FDA 483 - Broekman Instituut B.V.

Broekman Institute in Someren, Noord-brabant received a Form 483 with six observations primarily related to quality control, documentation, and environmental monitoring. Issues included a lack of deviation reports for bioburden exceedances, insufficient validation data for storage bags, and untimely closure of non-conformance reports and CAPAs. The findings indicate significant deficiencies in the firm's quality management system and control over manufacturing processes.