The Goa plant is one of the company’s largest manufacturing locations for exports, and the observations could affect the company’s trade with the US, media reports had said.
The company’s stock fell as much as 7% in morning trade on the news.
However, the company said the observations were “procedural” and specific to a particular application it had made for a particular product, and would have no impact on other products manufactured there.
“At this stage, we do not foresee any impact on the other products being manufactured/filed from the plant. Post this inspection, we have received 2 product approvals from the plant,” it said.
Cipla did not specify what the adverse observations were.
However, it said, the US FDA conducted “a product specific pre-approval inspection” at the plant in January 2018.
“We received certain observations which are procedural in nature. We have already responded to the agency on all the observations,” it added.
After the clarification, the company’s stock bounced back and is now trading at around Rs 555, or down less than 1% over previous close.