FDA 483 - Biograft Transplant Services Inc - August 27, 2021
Discuss this record with AI
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.
An FDA inspection of Biograft Transplant Services Inc in Houston, TX, a human tissue establishment, revealed significant deficiencies in environmental monitoring and control within their recovery suite. The firm failed to monitor for microorganisms, control humidity, and maintain documentation for temperature control, raising concerns about potential contamination of human cells, tissues, and cellular and tissue-based products (HCT/Ps). These issues suggest a lack of adequate controls to prevent contamination and ensure product safety.
ID · 7c9a3595-838a-4b86-bc7c-27aea562d822