FDA 483 - ADMA Biologics, Inc
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An FDA inspection of ADMA Biologics Inc. in Boca Raton, FL, revealed significant deficiencies across multiple areas, including data integrity, document control, investigation processes, quality unit responsibilities, equipment qualification, test procedures, facility maintenance, and sanitization effectiveness. These issues indicate a systemic lack of adequate controls and adherence to established procedures, posing potential risks to product quality and patient safety. The report highlights repeat observations, suggesting persistent non-compliance.
- Company
- ADMA Biologics, Inc
- Product Type
- Biologics
ID · f94a295e-b77d-4b72-959a-36c3f32fd427