# FDA EIR - Elaine M. Majerus, MD, PhD - June 17, 2020

Source: https://www.keypedia.com/records/eir/elaine-m-majerus-md-phd/0b7b0eb4-b20d-4542-8a9c-17d40689d018

> FDA EIR for Elaine M. Majerus, MD, PhD on June 17, 2020. Product: Biologics. Access full analysis and detailed observations.

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## Details

- Record Type: EIR
- Company Name: Elaine M. Majerus, MD, PhD
- Inspection Date: 2020-06-17
- Product Type: Biologics
- Office Name: Center for Biologics Evaluation and Research
- Summary: An FDA inspection of Clinical Investigator Elaine M. Majerus, MD, PhD, located in Saint Louis, MO, was conducted from June 15 to June 17, 2020. This was the initial FDA inspection of Dr. Majerus, performed as a high-priority comprehensive surveillance for a clinical investigator, in accordance with Compliance Program 7348.811. The inspection focused on the conduct of a specific protocol for which data was submitted to support a Biologics License Application (BLA). The audit covered a wide range of study records, including IRB approvals, informed consent forms, subject medical records, financial disclosures, case report forms, and training documentation. All screened and enrolled subject records were thoroughly reviewed for eligibility, adherence to the protocol, and accurate adverse event reporting. The inspection found no evidence of under-reporting of serious adverse events, adverse events, or protocol deviations. Significantly, no Form FDA 483, which would list objectionable conditions, was issued, indicating an absence of violations. No issues were discussed with Dr. Majerus at the inspection's conclusion. While no specific actions were required, Dr. Majerus was reminded of her responsibility to comply with the Food, Drug, and Cosmetic (FD&C) Act, with a warning that non-compliance could lead to future regulatory actions.

## Related Officers

- [recipient](https://www.keypedia.com/people/elaine-majerus/4b7ddaed-2a39-4183-a749-0fd81b5d3da7)
- [company_representative](https://www.keypedia.com/people/yi-zhang/7f5f3567-5f6e-4579-a978-00003fd841d4)
- [company_representative](https://www.keypedia.com/people/teresa-arb/a8e2075e-4cb0-42a9-a8a0-5d67e9052424)
- [issuing_officer](https://www.keypedia.com/people/karen-m-montgomery/ee91b1bb-8d51-4fdc-bee5-949441136e59)

Company: https://www.keypedia.com/companies/elaine-m-majerus-md-phd/90caa7ab-dab0-43e9-ad7b-982dc9f5f595

Office: https://www.keypedia.com/offices/center-for-biologics-evaluation-and-research/dd9e8ea7-6f04-4ed1-b0d7-e7e6b264570d