# FDA 483 - Maria W. Greenwald, MD - October 27, 2022

Source: https://www.keypedia.com/records/483/maria-w-greenwald-md/40214201-667e-45ff-b872-7abc409c79a4

> FDA 483 for Maria W. Greenwald, MD on October 27, 2022. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Maria W. Greenwald, MD
- Inspection Date: 2022-10-27
- Product Type: drugs
- Office Name: Food and Drug Administration
- Summary: An FDA inspection of Dr. Maria W. Greenwald, MD, a clinical investigator in Palm Desert, CA, was conducted from October 17-27, 2022. The inspection revealed significant concerns regarding compliance with clinical trial protocols and data integrity across multiple Investigational New Drug (IND) studies. The primary violations centered on Dr. Greenwald's failure to conduct investigations in accordance with signed statements and investigational plans. This included enrolling subjects who did not meet eligibility criteria, such as those with pre-existing conditions like Rheumatoid Arthritis (RA) or who were simultaneously participating in other systemic medication studies. Critically, subjects were co-enrolled and dosed in multiple trials, and prohibited concomitant medications were administered. These major protocol deviations were not reported to the study sponsors or Institutional Review Board (IRB). Furthermore, the inspection identified a failure to maintain adequate and accurate case histories. Numerous discrepancies were found in subject medical records, including inconsistent documentation of diagnoses (RA, Ankylosing Spondylitis), undocumented concomitant medications, and missing adverse event reports. These omissions undermine the reliability and accuracy of clinical trial data. These observations indicate a breakdown in adhering to the regulatory framework governing clinical investigations. Dr. Greenwald is expected to address these findings, implement comprehensive corrective and preventive actions, and ensure all future clinical research is conducted strictly according to approved protocols and regulatory requirements to safeguard data integrity and patient safety.

## Related Documents

- [483 - 2019-11-01](https://www.keypedia.com/records/483/maria-w-greenwald-md/843d31a4-9389-4c39-add6-7124bbf77dea)
- [483 - 2019-11-01](https://www.keypedia.com/records/483/maria-w-greenwald-md/fdb6d2da-6f63-4b6b-bd87-9d23be2689b1)
- [483 - 2022-10-27](https://www.keypedia.com/records/483/maria-w-greenwald-md/ca16735c-c0b9-4e59-898b-4be2bdc5261e)

## Related Officers

- [Shelby N. Turner](https://www.keypedia.com/people/shelby-n-turner/77268f33-ae48-4e30-abad-4d79c1077185)

Company: https://www.keypedia.com/companies/maria-w-greenwald-md/90154f09-36f0-47b8-af7a-477305fa8505

Office: https://www.keypedia.com/offices/food-and-drug-administration/437fdb2a-5048-42aa-aaea-ea28efe65516