# FDA 483 - John O Mascarenhas, M.D. - July 01, 2021

Source: https://www.globalkeysolutions.net/records/483/john-o-mascarenhas-md/64a3826d-ce15-4ba2-afee-b2ca6deae791

> FDA 483 for John O Mascarenhas, M.D. on July 01, 2021. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: John O Mascarenhas, M.D.
- Inspection Date: 2021-07-01
- Product Type: drugs
- Office Name: Division of Human and Animal Food Operations - East I
- Summary: An FDA inspection of John O Mascarenhas, M.D., a clinical investigator in New York, NY, identified two observations. The inspection found failures in maintaining adequate and accurate case histories, specifically regarding the reporting of adverse events and concomitant medications in the eCRF. Additionally, investigational records were not retained for the required period following drug marketing application approval.

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Office: https://www.globalkeysolutions.net/offices/division-of-human-and-animal-food-operations-east-i/a807f00e-d780-40b8-b233-1eb92ece8961