FDA puts Ansell condom plant in Thailand on detention

From Rubber & Plastics News

Melbourne, Australia-The US Food & Drug Administration has placed Ansell Ltd’s Surat Thani, Thailand, plant under ‘Level 2’ detention, meaning all shipments from that facility will have to undergo testing until at least 10 successive shipments pass inspection.

The FDA ordered the detention after two lots randomly selected for inspection failed to meet the agency’s defined standards, Melbourne-based Ansell said. All medical devices imported into the US are subject to lot testing by the FDA, Ansell said, and condoms are rated a…

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