FDA 483 - Women & Infants Hospital Of Rhode Island Women & Infants' Fertility Center - August 10, 2021

The FDA issued a Form 483 to Women & Infants Hospital Of Rhode Island Women & Infants' Fertility Center in Providence, RI, following an inspection of their human tissue (reproductive) establishment. The inspection revealed deficiencies in donor screening for communicable disease risk factors and in the timely collection of donor specimens for testing. These observations indicate potential non-compliance with regulations concerning donor eligibility and product safety.