# FDA 483 - James P. Lin, M.D., Inc. - March 05, 2020

Source: https://www.globalkeysolutions.net/records/483/james-p-lin-md-inc/860b72ca-102f-4ab6-966d-06815cbcacec

> FDA 483 for James P. Lin, M.D., Inc. on March 05, 2020. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: James P. Lin, M.D., Inc.
- Inspection Date: 2020-03-05
- Product Type: biologics
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: Lin Fertility Network, Inc. in Corona, CA, was inspected regarding its human reproductive tissue operations. The inspection revealed significant deficiencies in donor screening and labeling practices for human cells, tissues, and cellular and tissue-based products (HCT/Ps). These issues include inadequate labeling of HCT/Ps from ineligible donors, insufficient screening for communicable diseases like Zika Virus, and incomplete documentation of donor ineligibility reasons.

## Related Officers

- [investigator](https://www.globalkeysolutions.net/people/yvonne-c-wilkes/44e7b094-d09a-48f0-a0ee-f1a6506f935a)

Company: https://www.globalkeysolutions.net/companies/james-p-lin-md-inc/b180b349-824b-4a17-b778-d3dcbf062120

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