# FDA 483 - Beth E. Safirstein, M.D. - June 05, 2023

Source: https://www.keypedia.com/records/483/beth-e-safirstein-md/e9ef6c74-9e4b-42a5-9afe-6f2f4df28db9

> FDA 483 for Beth E. Safirstein, M.D. on June 05, 2023. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Beth E. Safirstein, M.D.
- Inspection Date: 2023-06-05
- Product Type: drugs
- Office Name: Office of Medical Device and Radiological Health Division II
- Summary: Beth E. Safirstein, M.D., a clinical investigator in Hallandale Beach, FL, was cited for failing to conduct an investigation in accordance with the signed statement of investigator and investigational plan. This involved multiple temperature excursions for investigational products and serum samples. Consequently, 92 subjects received improperly stored investigational product and 9 subjects received improperly stored investigational product during a booster visit, without proper quarantine of the affected materials.

## Related Officers

- [Richard A. Lyght](https://www.keypedia.com/people/richard-a-lyght/8d60b5c0-4acd-4abc-979a-fb4b3e82964d)

Company: https://www.keypedia.com/companies/beth-e-safirstein-md/9fdf7e95-e050-4f9d-bcd2-e00665e881c1

Office: https://www.keypedia.com/offices/office-of-medical-device-and-radiological-health-division-ii/ae9bd439-479a-420d-9dd8-9fe1fc0863d6