483
Broekman Instituut B.V.FDA 483 - Broekman Instituut B.V.
Record Details
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.
- Company
- Broekman Instituut B.V.
- Product Type
- Biologics
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ID · 08611032-4be7-4153-8f30-8577121f3df8