The company proposes to address this observation in the next 15 days
JB Chemicals and Pharmaceuticals said its Gujarat unit has passed the US health regulator’s periodical inspection with one minor procedural observation. The company’s solid oral dosage forms formulations manufacturing facility at Panoli, Gujarat, has successfully passed periodical inspection by US FDA with one minor procedural observation, JB Chemicals and Pharmaceuticals said in a filing to BSE. This observation does not impact continuity of the business and the company would continue its manufacturing activities in current good manufacturing practice (cGMP) compliant manner, it said.
The company proposes to address this observation in the next 15 days. “The said inspection was carried-out from February 3, 2020 to February 7, 2020,” as per the filing.