Fertility Specialists of Texas PLLC.March 18, 2019

FDA 483 - Fertility Specialists of Texas PLLC. - March 18, 2019

View on Dashboard

Discuss this record with AI

ChatGPT

Claude

Perplexity

Grok

Copilot

Document or profile

One record shows the event. A profile shows the pattern.

Buy this document for the source file and details behind this single event.

Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.

Explore Fertility Specialists of Texas PLLC.

Record Details

Fertility Specialists of Texas PLLC in Frisco, TX, was inspected and cited for significant deficiencies in their donor screening processes for Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps). Observations included inadequate screening for communicable disease agents like ZIKA virus due to incomplete donor history questionnaires. Additionally, the firm lacked comprehensive written procedures for physical examinations and determining donor eligibility.

Company: Fertility Specialists of Texas PLLC.
Inspection Date: March 18, 2019
Product Type: Biologics
Office: Dallas District Office
Person: Decarlos A. Gomez

Open in Dashboard

ID · 8e3aa0e6-d9b0-42bf-b885-51fa6a2276f3