# FDA 483 - David M. Lubeck MD - April 20, 2022

Source: https://www.keypedia.com/records/483/david-m-lubeck-md/2d84c34a-a5c0-4e76-af99-2034b5e45c96

> FDA 483 for David M. Lubeck MD on April 20, 2022. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: David M. Lubeck MD
- Inspection Date: 2022-04-20
- Product Type: drugs
- Office Name: Chicago District Office
- Summary: David M. Lubeck MD, a sponsor-investigator in Orland Park, IL, was cited for significant deficiencies in conducting a clinical investigation. The firm initiated an IND-required study before the IND was in effect, failed to maintain adequate case histories, and did not follow the investigational plan. These issues indicate a lack of adherence to regulatory requirements for clinical trials.

## Related Officers

- [issuing_officer](https://www.keypedia.com/people/yuanyuan-li/2043568b-a6ac-4f49-8018-c2c8edda8ac5)

Company: https://www.keypedia.com/companies/david-m-lubeck-md/5e1c55da-2d70-4524-b484-85704dab6f3b

Office: https://www.keypedia.com/offices/chicago-district-office/a510300b-0eaf-4a33-90b5-231d95977669