# FDA EIR - Myron Reiff, M.D. - June 27, 2019

Source: https://www.keypedia.com/records/eir/myron-reiff-md/6a76bfd4-85a0-4268-a031-5aeaee273278

> FDA EIR for Myron Reiff, M.D. on June 27, 2019. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: EIR
- Company Name: Myron Reiff, M.D.
- Inspection Date: 2019-06-27
- Product Type: drugs
- Office Name: Los Angeles District Office
- Summary: A For Cause inspection of Myron Reiff, M.D., located in Bellflower, CA, was conducted by the FDA from June 20 to June 27, 2019. The inspection focused on the conduct of clinical investigations, specifically a study where Dr. Reiff served as Principal Clinical Investigator, under the regulatory framework of Compliance Program 7348.811 and Good Clinical Practices. The inspection uncovered significant violations, primarily that the investigation was not conducted in accordance with the signed statement of the investigator and the investigational plan. Key issues included the backdating of several subjects' progress notes by months, with Dr. Reiff admitting to these actions during the inspection. Furthermore, a screen-failed subject with a critical abnormal lab result received no documented medical care or physician recommendation. Several subjects were found to have been improperly enrolled, violating inclusion/exclusion criteria by participating in multiple investigational drug studies concurrently. The same individual served as caregiver/informant for multiple subjects, raising concerns about the impartiality of data collection. The report also highlighted a general lack of adequate investigator oversight, as Dr. Reiff admitted to serious GCP violations and appeared to be heavily influenced by other site personnel. As a result, an FDA 483, Inspectional Observations, was issued to Dr. Reiff. He was instructed to submit a written response to the Dallas District office within 15 business days addressing the identified deficiencies.

## Related Documents

- [483 - 2019-06-27](https://www.keypedia.com/records/483/myron-reiff-md/9df20ec6-32b5-4806-9a6c-acc97bea6942)

## Related Officers

- [CSO](https://www.keypedia.com/people/andrea-a-branche/9ffe9b53-7963-49a6-be4e-25e644f1759f)
- [investigator](https://www.keypedia.com/people/myron-reiff/e2a5b6ff-652e-4d65-a143-180bb4cfd00a)

Company: https://www.keypedia.com/companies/myron-reiff-md/289250fc-f1bc-4480-8477-8b2ad90accfa

Office: https://www.keypedia.com/offices/los-angeles-district-office/edcf1dfe-596a-43b8-8df4-07d9cd94763b