FDA Threatens to Block Imports from Two Indian Drug Companies for CGMP VIolations
The Food and Drug Administration threatened two Indian drug companies with refusal of their products at the border for violations of current good manufacturing practice requirements. FDA told Posh Chemicals in a warning letter Aug. 2 that active pharmaceutical ingredients…
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(APIs) from its facility in Hyderabad may face import alert and detention without physical examination unless CGMP violations are corrected (here). And in a warning letter sent Aug. 9, FDA told Sentiss Pharma (formerly Promed Exports) that it will continue to refuse finished pharmaceuticals already subject to DWPE from the company’s Khera Nihla Village facility for uncorrected CGMP violations (here).