U.S. health regulator FDA has found nine possible procedural deviations in a manufacturing plant of Dr. Reddy’s Laboratories during a recent inspection and has sought reply from the drug maker on these issues.
The company is in the process of responding to the FDA’s observations, a Dr. Reddy’s spokesperson said.
“We have received nine inspectional observations from the U.S. FDA after their visit to our API (active pharmaceutical ingredients) manufacturing facility in Srikakulam district in Andhra Pradesh.
“We will respond to the agency within the stipulated timelines with our remedial plans and start implementing the necessary measures immediately,” the official told PTI. These observations largely related to procedural and other compliances of the plant systems. At this stage, production continued in the normal course, and there was no implication on any activity at the plant, the spokesperson added. According to analysts, the company received ‘Form 483’ observations from USFDA for its unit 6 of the Vizag plant.
