483
Lawrence Werlin MD, Inc. dba Coastal Fertility Medical CenterLawrence Werlin MD, Inc. dba Coastal Fertility Medical Center – FDA 483, Jan 9, 2026
Record Details
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.
- Inspection date
- January 9, 2026
- Product type
- biologics
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ID · c6a69399-d35c-4a09-9b54-7ace39175eb9
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