Friday, 27 January 2017

Disclose The Observations Made By US FDA’s first time Inspection Of Granules OmniChem’s Vizag Facility

Click here to read Form 483
Granules OmniChem facility, a 50:50 joint venture company of Granules India Limited and Ajinimoto OmniChem N.V., located at Vizag, Andhra Pradesh, completed its first inspection by U.S. FDA with 7 observations. Granules OmniChem Pvt. Ltd. will respond to these observations within the stipulated time period. This facility currently manufactures API intermediates. 
While the inspection took place and concluded from the 5-9 December, 2016; the company did not disclose this fact until the 19th December. In its regulatory filing.