An API manufacturing facility of generic drugmaker Dr. Reddy’s Laboratories in Srikakulam, Andhra Pradesh, has received United States Food and Drug Administration’s establishment inspection report (EIR) with a voluntary action indicated classification.

The facility (CTO-6) was inspected by the U.S. FDA from May 30-June 7 and issued a Form 483 with four observations. The company had then said the observations will be addressed within the stipulated timeline.

In a filing on Friday, Dr. Reddy’s said the company has received the EIR. The U.S. FDA has classified the inspection as VAI and concluded that the inspection is closed under 21 CFR 20.64(d)(3). The company’s shares ended with a less than 1% increase at ₹6,669.75 each on the BSE.

A Form 483 is issued by the U.S. FDA to notify the respective company’s management of objectionable conditions, during inspection, observed by its investigators that may constitute violations of the Food Drug and Cosmetic Act and related Acts. Subsequently, the U.S. FDA classifies inspections as No action indicated (NAI), which means no objectionable conditions or practices were found during inspection; VAI that means objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action; and Official action indicated (OAI) that translates into regulatory and/or administrative actions are recommended.