# FDA 483 - John Kumar Jain MD Inc. - February 08, 2019

Source: https://www.keypedia.com/records/483/john-kumar-jain-md-inc/2a413aad-7f65-4ba4-b426-58f9da932414

> FDA 483 for John Kumar Jain MD Inc. on February 08, 2019. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: John Kumar Jain MD Inc.
- Inspection Date: 2019-02-08
- Product Type: biologics
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: An FDA inspection of John Kumar Jain MD Inc., a reproductive establishment in Santa Monica, CA, on February 7-8, 2019, identified one observation. The firm failed to adequately screen donors for communicable disease agents, specifically regarding Zika virus, due to deficiencies in their donor screening questionnaire. This indicates a significant lapse in donor eligibility determination processes.

## Related Officers

- [Laurissa S. Flowers](https://www.keypedia.com/people/laurissa-s-flowers/27453525-c2fc-4a05-9cdc-7a1ed884304f)

Company: https://www.keypedia.com/companies/john-kumar-jain-md-inc/cf1a0277-6c8a-4c55-9df7-91c473fef357

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