BARR LABS OUT-OF-SPEC TEST RESULTS FOR ALL REINTRODUCED PRODUCTS MUST BE REPORTED TO FDA FOR TWO YEARS AFTER VALIDATION APPROVAL, CONSENT ORDER DECREES
Barr Labs is required to inform FDA of every out-of- specification test result concerning any previously suspended product for which the company has received agency approval to reintroduce, according to a Nov. 7 consent order issued by Newark, N.J. federal court Judge Alfred Wolin.
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