# FDA 483 - Eric Hollander MD - October 20, 2020

Source: https://www.keypedia.com/records/483/eric-hollander-md/d8149a1a-f617-4c47-80dd-5330f132629d

> FDA 483 for Eric Hollander MD on October 20, 2020. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Eric Hollander MD
- Inspection Date: 2020-10-20
- Product Type: drugs
- Office Name: Division of Human and Animal Food Operations - East I
- Summary: An FDA inspection of Eric Hollander MD in Bronx, NY, revealed a significant issue regarding the conduct of an investigational plan. The firm failed to document phone call interviews and questionnaires used to evaluate patients for signs and symptoms of infection, affecting all six subjects in a study's Open Label Extension phase. This indicates a lack of adherence to study protocols and proper record-keeping.

## Related Officers

- [Omadevi Somai](https://www.keypedia.com/people/omadevi-somai/8a6212bf-2dfa-44ea-bd2f-f2aeb78aa1bd)

Company: https://www.keypedia.com/companies/eric-hollander-md/be7e4f7e-33eb-4ad6-bd2f-f0e2e789ae45

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