# FDA 483 - Donald J Garcia, Jr. M.D. - April 01, 2021

Source: https://www.globalkeysolutions.net/records/483/donald-j-garcia-jr-md/613d6380-3165-455b-a2b0-d7c43d3b711d

> FDA 483 for Donald J Garcia, Jr. M.D. on April 01, 2021. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Donald J Garcia, Jr. M.D.
- Inspection Date: 2021-04-01
- Product Type: drugs
- Office Name: Division of Human and Animal Food Operations - West III
- Summary: An FDA inspection of Donald J Garcia, Jr. M.D., a clinical investigator in Austin, TX, revealed a significant failure to comply with regulations regarding informed consent. The firm did not ensure that informed consent was obtained from human subjects prior to conducting study-related tests, specifically urine screening for eligibility. This indicates a lapse in protecting human subjects participating in clinical trials.

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