# FDA 483 - Maria W. Greenwald, MD - November 01, 2019

Source: https://www.globalkeysolutions.net/records/483/maria-w-greenwald-md/843d31a4-9389-4c39-add6-7124bbf77dea

> FDA 483 for Maria W. Greenwald, MD on November 01, 2019. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Maria W. Greenwald, MD
- Inspection Date: 2019-11-01
- Product Type: drugs
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: An FDA inspection of Maria Greenwald, MD, a clinical investigator in Palm Desert, CA, revealed a significant deficiency in record-keeping practices. The firm failed to prepare or maintain adequate and accurate case histories, specifically regarding the availability of required chest x-rays and discrepancies in subject randomization records. This indicates a severity related to data integrity and protocol adherence in clinical investigations.

## Related Documents

- [483 - 2022-10-27](https://www.globalkeysolutions.net/records/483/maria-w-greenwald-md/ca16735c-c0b9-4e59-898b-4be2bdc5261e)

## Related Officers

- [Mendoza O. Wallace](https://www.globalkeysolutions.net/people/mendoza-o-wallace/a5ae81ea-3d0f-4b96-8012-e0d50a0e1967)
- [issuing_officer](https://www.globalkeysolutions.net/people/diane-c-van-leeuwen/98af0d70-2db1-4132-8193-fcccf8841960)

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

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