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FDA doesn’t enforce standards for sterile healthcare products manufacturer

Journal Sentinel, June 28, 2011
It's impossible for the public to know when regulators first discovered Bacillus cereus at H&P Industry's plant because the FDA heavily redacted details from a decade's worth of inspection reports provided to the Journal Sentinel under the Freedom of Information Act. Records do show inspectors found the bacterium - which was the basis for the January recall of the alcohol wipes - during their weeks-long inspection starting Nov. 29. That was revealed only after the newspaper challenged the redaction. The newspaper's review shows H&P had serious problems including trouble with cleanliness - and that FDA inspectors knew it - as far back as 2000. Medikmark Inc., an Illinois company that sold medical kits that included Triad products, alleges Triad was aware of sterility issues as early as 2002 and continuing until the recent product recalls. "The products Medikmark purchased from Triad were unreasonably and inherently dangerous," according to a lawsuit Medikmark filed this year after the nationwide recall of antiseptic wipes. Triad has strongly denied the allegations, saying its products met FDA requirements.