The US health regulator has imposed an import ban on products made at Dr Reddy's Laboratories' Mexican plant for violation of current good manufacturing practices (CGMP).
According to a notice on the US Food and Drug Administration (USFDA), the American drug regulator has imposed an import ban on products made at Dr Reddy's Mexican arm -- Industrias Quimicas Falcon de Mexico SA for violation of good manufacturing practice rules.
The company's Mexican arm, which produces intermediates and active pharmaceutical ingredients had received a warning a letter from the USFDA last month.
The import ban follows a warning letter issued by the USFDA on June 3. The regulator cited "lack of corrective actions" by the firm after it had sought certain explanations following an inspection of the company's Mexico facility in November 2010.
The import alert on Dr Reddy's drugs was issued under the category of 'Detention without physical examination of drugs from firms which have not met drug GMPs'.
According to a notice on the US Food and Drug Administration (USFDA), the American drug regulator has imposed an import ban on products made at Dr Reddy's Mexican arm -- Industrias Quimicas Falcon de Mexico SA for violation of good manufacturing practice rules.
The company's Mexican arm, which produces intermediates and active pharmaceutical ingredients had received a warning a letter from the USFDA last month.
The import ban follows a warning letter issued by the USFDA on June 3. The regulator cited "lack of corrective actions" by the firm after it had sought certain explanations following an inspection of the company's Mexico facility in November 2010.
The import alert on Dr Reddy's drugs was issued under the category of 'Detention without physical examination of drugs from firms which have not met drug GMPs'.
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