FDA 483 - Woodstock Sterile Solutions Inc
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Woodstock Sterile Solutions received a Form 483 with seven observations during an inspection from May 24-28, 2021, highlighting significant deficiencies in their manufacturing operations. Key issues include inadequate cleaning validation for multi-product equipment, insufficient computer system controls, and a lack of proper cross-contamination prevention for potent and biologic drug products. The report also cited failures in documentation, raw material release, equipment logbook completeness, and microbiological testing procedures.
- Product Type
- Drugs
- Person
ID · ffd0020d-9317-417d-b8da-14754f091811