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483
•Alfred J. Rodriguez, M.D., P.A.•February 27, 2024

Alfred J. Rodriguez, M.D., P.A. – FDA 483, Feb 27, 2024

Record Details

An FDA inspection of Alfred J. Rodriguez, M.D., P.A., a reproductive clinic in Plano, TX, revealed significant deficiencies in their HCT/P donor screening and testing processes. The firm failed to ensure donor eligibility through adequate screening questionnaires and proper documentation. Additionally, their standard operating procedures for donor testing were found to be incomplete, omitting crucial communicable disease tests.

Company
Alfred J. Rodriguez, M.D., P.A.
Inspection date
February 27, 2024
Product type
biologics
Office
Division of Human and Animal Food Operations - West III
Person
  • Maira P. Brading (investigator)
View Company Profile

ID · ca3adbf9-8c24-4497-ab68-48426da5c61f

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