New Delhi: The US health regulator has issued an import alert for the drugs and drug products manufactured by Hyderabad-based Fleming Laboratories at its Nawabpet facility in Medak district.
As per the United States Food and Drug Administration (USFDA), an import alert 66-40 is named as “Detention without physical examination of drugs from firms which have not met drug GMPs.” This alert is issued by the US health regulator when an inspection has revealed that a firm is not operating in conformity with current good manufacturing practices (GMP’s).
“Detention without physical examination of drugs 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,” the FDA said on its website.
Established in 1995, Fleming Laboratories is in the business of manufacturing and supply of generic Active Pharmaceutical Ingredients (APIs) to the global pharmaceutical industry.
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