22 November 2019 The USFDA inspected Unit 4 as part of cGMP compliance and thereafter issued form 483 with 14 observations (this site has successfully closed inspection six times in the past). The inspector observed deficiencies in media fill studies representing the manufacturing process. Other notable observations were (a) sampling plan not representing worst-case activities and (b) deficiency in systems for maintaining any equipment used to control aseptic conditions. All these observations showed deficiency in the assuring aseptic processes in the manufacture of sterile products. Over the past one year, eight sites have been inspected by the USFDA. Units 1 and 11 have been classified as Official Action Indicated (OAI) and Unit 9 has been issued a warning letter recently. Unit 7 is issued form 483 with seven observations. Units 5 and 8 were issued form 483 with four observations each. Excluding sales from Eugia, Units 12/16 and Auronext, Unit 4 would form ~7-8% of USD1.5b US annual sales.