# FDA 483 - Daniel Fred Goodman, M.D. - November 25, 2024

Source: https://www.keypedia.com/records/483/daniel-fred-goodman-md/212bafb7-40ab-4957-ad34-6a798faecbc8

> FDA 483 for Daniel Fred Goodman, M.D. on November 25, 2024. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Daniel Fred Goodman, M.D.
- Inspection Date: 2024-11-25
- Product Type: drugs
- Office Name: San Francisco District Office
- Summary: An FDA Form 483 was issued to Daniel Fred Goodman, M.D., operating as Goodman Eye Center, following an inspection conducted from November 20-25, 2024. The inspection, an OAI follow-up to a Warning Letter issued in July 2022, identified a significant observation related to the conduct of clinical investigations. The primary issue noted was the failure to properly investigate and document protocol deviations. Specifically, for an identified protocol, two deviations occurred during the study. However, the clinical investigator did not evaluate or document their impact on subject safety or data integrity. Furthermore, there was a lack of documentation regarding the need for corrective and preventive actions, and the assessment of reportability requirements to both the Institutional Review Board (IRB) and the study Sponsor. This observation highlights a non-compliance with the firm's signed statement of investigator and the investigational plan, crucial components of the regulatory framework governing clinical research under the Federal Food, Drug, and Cosmetic Act. While the FDA Form 483 itself lists observations rather than mandated actions, it requires Daniel Fred Goodman, M.D. to implement timely and effective corrective actions to address these deficiencies, ensuring adherence to regulatory standards for clinical trials and protecting research participants.

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## Related Officers

- [Scott N. Lim](https://www.keypedia.com/people/scott-n-lim/d5e7745a-d804-48d1-8f3b-a94a8d4aed8a)

Company: https://www.keypedia.com/companies/daniel-fred-goodman-md/75721ae4-0e50-488f-bbb5-22b050bc0249

Office: https://www.keypedia.com/offices/san-francisco-district-office/6f838e9c-aae1-4665-9c46-a51d43be02df