# FDA 483 - Patrick S. Lynch, MD - April 19, 2021

Source: https://www.keypedia.com/records/483/patrick-s-lynch-md/003eec55-fcfa-42e6-bd60-2cda7f85f215

> FDA 483 for Patrick S. Lynch, MD on April 19, 2021. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Patrick S. Lynch, MD
- Inspection Date: 2021-04-19
- Product Type: drugs
- Office Name: Division of Human and Animal Food Operations - West III
- Summary: An FDA inspection of Patrick S. Lynch, MD in Houston, TX, revealed significant deficiencies in clinical trial conduct. Observations included failures to promptly report serious adverse events to the sponsor, non-adherence to the study protocol regarding subject assessments, and improper documentation of informed consent forms. These findings indicate a need for improved oversight and adherence to regulatory requirements for clinical investigations.

## Related Officers

- [investigator](https://www.keypedia.com/people/zerita-white/82b19f0c-bd17-4a44-8523-8986f38851a8)

Company: https://www.keypedia.com/companies/patrick-s-lynch-md/26ed2e3d-7c61-42b1-a4ba-a416a03527bb

Office: https://www.keypedia.com/offices/division-of-human-and-animal-food-operations-west-iii/2cda09a5-06c4-433f-9df0-0d7903a6efab