STAT+: An API supplier in India wants you to know its metal detector is working just fine
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For those wondering about any metallic particles found in active pharmaceutical ingredients made by a supplier called Hikal, you can rest easy \u2014 the company says its metal detector is working again.<\/p>\n
Since 2020, nearly two dozen complaints were made to the manufacturer about black particles found in active ingredients following modifications made to a production plant. Yet during questioning by Food and Drug Administration inspectors last February, the company maintained that an internal investigation found the contamination was \u201ctechnically unavoidable.\u201d<\/p>\n
How so? At first, Hikal suggested there was a cleaning problem and acknowledged that the particles were \u201cmetallic in nature.\u201d However, these were \u201cbeyond the detection limit of [the] metal detector used to remove metallic particles\u201d in the active ingredients, according to an Aug. 20 warning letter<\/a> that the agency sent to the company and posted on the FDA website on Tuesday.<\/p>\n Continue to STAT+ to read the full story\u2026<\/a><\/p>\n<\/div>\n