Two minor observations were observed
JB Chemicals and Pharmaceuticals said that the US health regulator has completed the inspection of its Panoli facility in Gujarat with two minor observations.
“The company’s API manufacturing facility at Panoli, Gujarat has successfully passed periodical inspection by the US Food and Drug Administration (US FDA) with two minor procedural observations,” JB Chemicals and Pharmaceuticals said in a BSE filing today.
The company said these observations do not impact the continuity of its business and it would continue its manufacturing activities in a Current Good Manufacturing Practice (CGMP)-compliant manner.
“The company proposes to address these observation in next 30 days,” it added.
The inspection was carried out from May 7 to May 11, 2018. This US FDA/EU/Japan approved API facility primarily manufactures APIs for exports to EU and formulations exports to the US.