483
Women & Infants Hospital Of Rhode Island Women & Infants' Fertility CenterWomen & Infants Hospital Of Rhode Island Women & Infants' Fertility Center – FDA 483, Aug 10, 2021
Record Details
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.
- Inspection date
- August 10, 2021
- Product type
- biologics
- Person
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ID · 659b614d-adbc-4324-b51a-cf885da3f8c5
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