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Shelhigh Settles with FDA

Shelhigh Inc. on Friday settled its dispute with FDA over possible contamination of its tissue-based products, reports the Star-Ledger of Newark, NJ. It signed a consent decree to stop distributing products until it meets GMP requirements. It does not have to recall its products, as FDA requested, and can resume certain phases of manufacturing. But it does have to hire outside consultants to audit its facilities.

June 25, 2007

1 Min Read
Shelhigh Settles with FDA

Shelhigh Inc. on Friday settled its dispute with FDA over possible contamination of its tissue-based products, reports the Star-Ledger of Newark, NJ. It signed a consent decree to stop distributing products until it meets GMP requirements. It does not have to recall its products, as FDA requested, and can resume certain phases of manufacturing. But it does have to hire outside consultants to audit its facilities.

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