FDA 483 - ADMA Biologics, Inc

An FDA inspection of Biotest Pharmaceuticals in Boca Raton, Florida, revealed multiple significant deficiencies across its manufacturing and quality control operations. Key issues included inadequate process and cleaning validations, incomplete investigations into critical deviations, and insufficient control over samples and microbiological media. These findings highlight a need for substantial improvements in the firm's quality systems and adherence to good manufacturing practices.