Sun Pharmaceutical, one of the world’s largest generic drugmakers, was scolded by the U.S. Food and Drug Administration for a host of serious manufacturing violations at a key plant in India, the latest instance in which the company was tagged by the regulator for quality-control problems.
In a Dec. 15 warning letter posted on Tuesday on the FDA website, Sun was cited for several notable failures, such as not following appropriate procedures to prevent contamination; establishing an adequate system for monitoring environmental conditions; using suitable equipment; thoroughly investigating discrepancies in batches of products; or cleaning and sterilizing equipment.
More specifically, the company waited more than five months to issue a recall for a batch of medicines known to be affected by quality control problems and used equipment two years after these were identified for causing cross-contamination.
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