This was a product pre-approval inspection by USFDA for Pegfilgrastim, which company has partnered with Mylan. This biosimilar is branded as Fulphila.
USFDA, on June 4, 2018 approved Biocon and Mylan’s Pegfilgrastim Biosimilar. This approval already was an indication that the site would get clearance soon. As per the EIR, inspection for this site stands closed.