Dr Reddy's bulk drugs unit in Andhra gets US FDA fiat on procedural lapses

The US Food and Drug Administration (FDA) raised the issue of procedural deviations at Dr Reddy's Laboratories'(DRL) manufacturing plant in Andhra Pradesh and the US regulator has issued a `Form 483' fiat to the Indian drug maker.

The FDA is reported to have observed nine procedural lapses at Dr Reddy's active pharmaceutical ingredients (API) facility at the Srikakulam district of Andhra Pradesh.

The US regulator has sought a reply from the drug maker on these issues and the company is in the process of responding to the US health regulator's observations, a Dr Reddy's spokesperson said.

An FDA team had recently inspected the site and the company confirmed the development stating that the observations were largely related to the procedural and compliant system of the plant.

"We have received nine inspectional observations from the US FDA after their visit to our API manufacturing facility in Srikakulam district. We will respond to the agency within stipulated timelines with our remedial plans and start implementing the necessary measures immediately," reports quoted a spokesman of the company as saying.

As per the US regulator's website, during an inspection, FDA 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.

DRL should respond to the FDA within 15 working days, addressing each item, indicating agreement and either providing a timeline for correction or requesting clarification of what the FDA requires.

DRL said the observations are largely related 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," a company spokesperson said.

An increasing number of domestic pharma companies, such as Ranbaxy, Wockhardt, Sun Pharmaceutical and Strides Arcolab have come under US regulatory scrutiny in recent times.

With the US FDA now having its office in India, the frequency of such regulatory inspections have also increased.