# FDA 483 - Lawrence Werlin MD, Inc. dba Coastal Fertility Medical Center - January 09, 2026

Source: https://www.keypedia.com/records/483/lawrence-werlin-md-inc-dba-coastal-fertility-medical-center/c6a69399-d35c-4a09-9b54-7ace39175eb9

> FDA 483 for Lawrence Werlin MD, Inc. dba Coastal Fertility Medical Center on January 09, 2026. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Lawrence Werlin MD, Inc. dba Coastal Fertility Medical Center
- Inspection Date: 2026-01-09
- Product Type: biologics
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: An FDA inspection of Lawrence Werlin MD, Inc. dba Coastal Fertility Medical Center in Irvine, CA, identified two observations. The firm failed to adequately screen oocyte donors for communicable disease risk factors and did not properly label Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) from donors with incomplete screening. These issues indicate deficiencies in donor eligibility determination and product control.

## Related Documents

- [483 - 2022-12-22](https://www.keypedia.com/records/483/lawrence-werlin-md-inc-dba-coastal-fertility-medical-center/28691910-ec15-432b-b861-042e0686d74d)

## Related Officers

- [Melsomar R. Ramos](https://www.keypedia.com/people/melsomar-r-ramos/395e7ddc-ed98-455a-a143-0ee5f46804f4)

Company: https://www.keypedia.com/companies/lawrence-werlin-md-inc-dba-coastal-fertility-medical-center/f84196f4-f76b-4561-b7c0-ee434546f2fa

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