For those wondering about any metallic particles found in active pharmaceutical ingredients made by a supplier called Hikal, you can rest easy — the company says its metal detector is working again.
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 “technically unavoidable.”
How so? At first, Hikal suggested there was a cleaning problem and acknowledged that the particles were “metallic in nature.” However, these were “beyond the detection limit of [the] metal detector used to remove metallic particles” in the active ingredients, according to an Aug. 20 warning letter that the agency sent to the company and posted on the FDA website on Tuesday.
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