USFDA bans import of products from Dr Reddy's Mexico plant

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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'.

When contacted a Dr Reddy's Laboratories spokesperson said that the company could not comment on the specifics at this moment.
According to USFDA, it can detain without physical examination any drug when an FDA inspection has revealed that a firm is not operating in conformity with current good manufacturing practices (GMP's).

DWPE of such firms remains in effect until such time as FDA is satisfied that the appearance of a violation has been removed, either by re inspection or submission of appropriate documentation to the responsible FDA Centre.


 

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