FDA EIR - Biotest Pharmaceuticals Corporation - March 17, 2021

An FDA Level I inspection of Biotest Pharmaceuticals Corporation, a licensed Source Plasma Donor Center in San Antonio, TX, was conducted from March 12 to March 17, 2021. The inspection followed regulatory frameworks including the FY21 Plasma Inspection – Plasma Center and CP 7342.002 for Source Plasma Establishments, adhering to the Inspection Plan for Onsite inspections during the COVID-19 Pandemic. Key operational systems reviewed included Quality Assurance, Donor Eligibility, Product Testing, Product Collection and Processing, and Quarantine/Storage/Disposition. The comprehensive review encompassed operational processes, staff interviews, and an examination of records related to donors, equipment maintenance, quality control, complaints, deviations, training, and storage. Notably, the inspection identified no objectionable conditions or employee practices. Consequently, no FDA-483 (Inspectional Observations) was issued, and the firm’s current FDA registration (License Number 1792) for collecting, preparing, storing, and shipping blood products was confirmed. Given the absence of issues, no specific corrective or required actions were mandated by the FDA following this inspection.