12 October 2019 Out of the 12 observations issued in the form 483 by the USFDA, one is related to cleaning/maintenance of equipment, wherein procedures lack provision for routine cleaning of inlet/outlet duct areas. One more observation is related to systems being deficient for maintaining equipment used to control aseptic condition. In fact, all inspections, except at the Goa site, are now classified as VAI (voluntary action indicated) or NAI (no action indicated), implying a minimal regulatory risk at these sites. Note that the Bangalore site was recently inspected in Jun19 and issued a form 483 with seven observations, which was now followed by the Goa site inspection. However, a higher quantum of sales from this site can be shifted to other sites in case the regulatory situation worsens at Goa. Moreover, while the company is implementing remediation measures, there are low single-digit ANDAs pending for approval from this site over the next 12-15 months, implying a minimal impact on future growth as well.