Dr Reddy's Laboratories Limited's Active Pharmaceutical Ingredients (API) plant in Mirfield, UK, has received three inspectional observations (Form 483) from the US Food and Drug Administration (US FDA) following the completion of its audit yesterday.
The company's US FDA
approved the site at Mirfield has two dedicated API
manufacturing facilities, a GMP pilot plant and kilo lab, a commercial facility for intermediates manufacture.
"This is to inform you that audit of our API
Mirfield plant, UK, by the US FDA
has been completed today. We have been issued Form 483 with three observations, which we are addressing," the company said in the filing posted in the late evening yesterday.
Mirfield plant is the latest addition to a group of facilities of Dr Reddy's back in India that received Form 483 with observations from US FDA
and some of them were put under scanner by the German Regulatory Authority in the past few weeks.
The inspectional observations do not presuppose any adverse ruling by the drug regulator and are often addressed by appropriate corrective steps by the companies
without attracting any regulatory actions. Some facilities clear the audit with zero observations.
However, in case of Dr Reddy's, some of the 'Form 483' observations subsequently resulted in the issuance of a warning letter for three of its facilities in November 2015 besides receiving a new set of observations in re-audits despite the implementation of the corrective steps.
This is the first time in recent years that one of the overseas facilities of the company was not able to clear the audit with no observations. It may be recalled that Dr Reddy's had received its first warning letter in 2011 on quality compliance issues related to its chemical plant in Mexico. The subsequent import alert on this facility was lifted by the US FDA
in the following year.