Ranbaxy woes revealed in FDA warning letter
pharmafile | February 9, 2010 | News story | Manufacturing and Production |Â Â RanbaxyÂ
Ranbaxy has not taken adequate measures to correct deficiencies at its manufacturing plants, according to a communication from the US Food and Drug Administration.
The FDA has warned that the measures taken by Ranbaxy to set its manufacturing facilities in order have not yet passed muster, with the agency requesting a thorough appraisal of all the plants supplying products into the US market.
The comments, made in a warning letter sent to the drugmaker on December 21 but only made public on the FDA’s website last week, include that “Ranbaxy’s attempts to make global corrections after past regulatory actions by the FDA have been inadequate”.
The latest letter details violations at Ranbaxy’s US manufacturing unit Ohm Laboratories, and specifically a liquid pharmaceutical production facility in Gloversville, New York.
Ranbaxy has already had a series of warnings from the FDA regarding plants in Dewas and Paonta Sahib, India, that export generics to the US, which led to the agency levying an import ban on products made at the two facilities.
“FDA expects Ranbaxy immediately to undertake a comprehensive assessment of its global manufacturing operations to ensure that all sites manufacturing drugs for the US market conform to US requirements,” the letter concludes.
Among the problems identified in the letter are violations in current Good Manufacturing Practice (cGMP) standards, including a lack of investigation into batch failures caused by contaminating particles.
Issues relating to laboratory control mechanisms are noted, including a failure to set effective quality control standards and operating procedures, such as systems to allow lab samples to be traced and stored properly.
The letter also lists post-marketing violations, such as a failure to provide accurate distribution data for medicines and notify FDA of failed batch within the specified timeframe, as well as violations relating to the sale of an unapproved drug.
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