# FDA 483 - Michael A. Hassman, DO - June 20, 2023

Source: https://www.keypedia.com/records/483/michael-a-hassman-do/fa2652e2-2cdf-4a20-870d-62d608d93e9e

> FDA 483 for Michael A. Hassman, DO on June 20, 2023. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Michael A. Hassman, DO
- Inspection Date: 2023-06-20
- Product Type: drugs
- Office Name: New Jersey District Office
- Summary: 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).

## Related Officers

- [investigator](https://www.keypedia.com/people/tyanna-n-hadley/8fdebfd7-d6f3-44ab-9dcb-864ab6d55d53)

Company: https://www.keypedia.com/companies/michael-a-hassman-do/9cf24bff-ac15-446a-843e-da77a222bbdc

Office: https://www.keypedia.com/offices/new-jersey-district-office/6ff5e2e9-5cff-44c7-af24-5a55329a8248
