483
CSL Behring AGCSL Behring AG – FDA 483, Feb 10, 2020
Record Details
CSL Behring AG in Bern, Switzerland, received a Form 483 with four observations related to its licensed biological manufacturing. The inspection revealed deficiencies in investigation records, procedures to prevent microbiological contamination, control of electronic forms, and calibration of instruments. These issues indicate potential risks to product quality and data integrity.
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ID · b976a269-69e7-4b85-abb2-05252697f77b
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