US FDA may inspect Dr Reddy’s Mexico facility this month

PTI Hyderabad | Updated on March 20, 2012 Published on March 20, 2012

American drug regulator US FDA, which issued an import alert on products made in the Mexico unit of India’s Dr Reddy’s Laboratories, may visit the facility for an inspection later this month, the company said.

In a statement to the Securities and Exchange Commission of USA, DRL said it believes that the Detention without Physical Examination (DWPE) alert issued by USFDA is of a temporary nature and that it is not expected to have a material long term effect on the company’s Mexican operations.

“The company is working collaboratively with the USFDA to resolve the matters contained in the warning letter, and has been informed of an inspection by the USFDA of its Mexico facility during the last week of March 2012,” the SEC filing said.

“Nonetheless, the company cannot be assured that satisfying the USFDA’s concerns will not take longer than currently anticipated or that the USFDA will not request additional corrective actions that would result in the DWPE remaining in effect longer than currently anticipated,” the filing added.

In November 2010, USFDA inspected the company’s Mexican facility and issued audit observations relating to the process for manufacture of Active Pharma Ingredients (API) and steroids, to which DRL responded by agreeing to implement certain corrective actions.

On June 3 last year, the company received a warning letter from the US regulator seeking further clarifications and corrective actions on some of the prior audit observations to which the company had previously responded.

On June 28, USFDA posted an import alert, or DWPE, on its Web site for certain specified products made at the facility.

The Mexico facility produces intermediates, API and steroids.

It is thus unable to export some API and steroids to its US customers.

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Published on March 20, 2012
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