483
Michael A. Hassman, DOMichael A. Hassman, DO – FDA 483, Jun 20, 2023
Record Details
An FDA inspection of Michael A. Hassman, DO in Berlin, NJ, a clinical investigator, revealed a significant deficiency in record retention. The firm failed to retain investigational records, specifically source data for subject assessments, for the required two-year period following drug marketing application approval. This indicates a critical lapse in data integrity for clinical study protocol (b) (4).
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ID · fa2652e2-2cdf-4a20-870d-62d608d93e9e
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