US FDA slaps ban on Dr Reddy’s Mexico products
07 Jul 2011
The US Food and Drug Administration has imposed an import ban on products made at Dr Reddy's Laboratories' Mexico unit for violation of manufacturing practice rules, after a warning issued by FDA last month.
Inustrias Quimicas Falcon de Mexico, as the facility of Dr Reddy's is called, had received a four-item warning letter from the FDA last month.
The wholly owned arm makes intermediates and active pharmaceutical ingredients (APIs). The unit also offers a range of services including analytics, process R&D and scale-up.
The FDA, which inspected the facility in 8-11 November 2010, identified significant deviations from current good manufacturing practice (GMP) regulations.
Tuesday's import alert was issued under the category of ''detention without physical examination of drugs''.
The ban remains in effect till the FDA is satisfied with the corrective measures.
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