BEST NEWS I'VE HAD IN YEARS
FDA has now conducted the Pre-License Inspection (PLI) of the manufacturing process for
remestemcel-L
FDA inspection did not result in the issuance of a Form 483, which is provided at the conclusion
of an inspection if investigators have observed any conditions that in their judgment may
constitute violations of the Food Drug and Cosmetic Act and related Acts
Establishment Inspection Report (EIR) is expected to be issued by FDA in the coming weeks
providing a detailed summary and final assessment of the inspection
Reg
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- Ann: MSB Reports Q3 Financial Results and Operational Highlights
Ann: MSB Reports Q3 Financial Results and Operational Highlights, page-2
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