# FDA 483 - Lawrence Werlin MD, Inc. dba Coastal Fertility Medical Center - December 22, 2022

Source: https://www.globalkeysolutions.net/records/483/lawrence-werlin-md-inc-dba-coastal-fertility-medical-center/28691910-ec15-432b-b861-042e0686d74d

> FDA 483 for Lawrence Werlin MD, Inc. dba Coastal Fertility Medical Center on December 22, 2022. Product: biologics. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Lawrence Werlin MD, Inc. dba Coastal Fertility Medical Center
- Inspection Date: 2022-12-22
- Product Type: biologics
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: The FDA inspected Lawrence Werlin MD, Inc. dba Coastal Fertility Medical Center, a reproductive fertility center in Irvine, CA. The inspection revealed significant deficiencies in donor screening and eligibility determination for oocyte donors, specifically regarding Zika and West Nile viruses. Additionally, the firm failed to maintain donor anonymity by including personal identifying information on accompanying HCT/P records.

## Related Officers

- [Celeta S. Coves](https://www.globalkeysolutions.net/people/celeta-s-coves/d0f63577-a6e4-4872-b06c-a024188a04ba)

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

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