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Pharmaceuticals / Inspections and Audits

FDA Raps ADMA Biologics for Poor Documentation, Data Controls

Aug. 29, 2018

The FDA cited ADMA Biologics for failure to implement proper document controls and prevent unauthorized changes to data in its computer systems.

The agency hit the drug manufacturer with a Form 483 after an April inspection of its Boca Raton, Fla., facility revealed deficiencies in the company’s controls for electronic data acquisition systems.

Specifically, the firm’s UV Spectrophotometer, used for total protein determination, lacked usernames/passwords and audit trails. ADMA’s coagulation analyzer also had a function that analysts could use to delete results.

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