# FDA 483 - Samer K. Khaled, M.D. - December 23, 2020

Source: https://www.keypedia.com/records/483/samer-k-khaled-md/1e0146ac-e795-4778-a44c-ba6bafbc983a

> FDA 483 for Samer K. Khaled, M.D. on December 23, 2020. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Samer K. Khaled, M.D.
- Inspection Date: 2020-12-23
- Product Type: drugs
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: The FDA inspected Samer K. Khaled, M.D., a clinical investigator in Duarte, CA, from December 17-23, 2020. The inspection revealed deficiencies in the timely reporting of adverse events and the maintenance of adequate case histories. Specifically, one serious adverse event was not reported until prompted by a study monitor, and three other adverse events were not entered into the electronic data capture system in a timely manner.

## Related Documents

- [EIR - 2020-12-23](https://www.keypedia.com/records/eir/samer-k-khaled-md/feae9844-6876-4aa6-9580-e5841ce377a3)

## Related Officers

- [issuing_officer](https://www.keypedia.com/people/kaitlyn-t-dang/640abfda-d492-4136-b11d-59ed9016bd97)

Company: https://www.keypedia.com/companies/samer-k-khaled-md/daa94244-9556-4238-a190-7d599a3b496a

Office: https://www.keypedia.com/offices/division-of-pharmaceutical-quality-operations-iv/a2d2ff91-dc0f-433e-b91f-ca90ff8998b6