Dr Reddy's plant gets USFDA fiat on suspected lapses

US 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 US 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 stipulated timelines with our remedial plans and start implementing the necessary measures immediately," the official told PTI.

These observations largely relate to procedural and other compliances of the plant systems. At this stage, production continues in the normal course and there is 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 Vizag plant.

As per FDA website, during an inspection, FDA's Office of Regulatory Affairs investigators may observe conditions they deem to be objectionable.
These observations, are listed on an FDA Form 483 when, in an investigator's judgment, the observed conditions or practices indicate that an FDA-regulated product may be in violation of FDA norms.

The plant, which manufactures active pharmaceutical ingredients and bulk drugs, was visited by the US Food and Drug Administration last week.
"According to the company, 483 observations are unlikely to affect the production of the company and therefore, it will continue as per normal routine," said Sarabjit Kour Nangra, VP - Research Pharma, Angel Broking.