Elan's inconsistent handling of out-of-specification results at Verelan plant cited in FDA warning letter.
ELAN INCONSISTENT HANDLING OF OUT-OF-SPECIFICATION RESULTS AT VERELAN PLANT is cited in a Nov. 7 FDA warning letter to the company. The letter states that Elan has "failed to appropriately investigate and respond to out-of-specification (OOS) analytical results," found in its Gainesville, Georgia plant, where it manufacturers the antihypertension drug Verelan (verapamil sustained-release) for Wyeth-Lederle. FDA inspected the plant between Aug. 25 and Sept. 17, 1997. A re-inspection date has not been scheduled.
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