FDA bans import of products from Dr Reddy’s Mexico site
The US Food and Drug Administration (FDA) has followed up a warning letter by banning imports from Dr Reddy’s Mexican API plant.
Following a 2010 inspection of the active pharmaceutical ingredients (API) plant in Jiutepec, Mexico the FDA sent Dr Reddy’s a warning letter. The agency has now imposed an import alert on the plant, banning the distribution of products in the US.
In its warning letter the FDA highlighted failures to validate analytical methods used to test APIs.“The inspection revealed that your firm has not validated the HPLC method for assay and related substances of [an unnamed finished API for human use]”, said the FDA.
