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Endo Gets 483 Over Laboratory Controls

February 14, 2011
Endo Laboratories received a Form 483 after it attributed out-of-specification results to poor performance of a high-performance liquid chromatography (HPLC) column, re-tested active pharmaceutical ingredient (API) lots and determined that all lots were within specification. The company’s Cranbury, N.J., facility has had additional periodic API failures that were retested based on the premise that the HPLC column failed, according to the Nov. 9, 2010, form. The company is investigating whether its previously validated testing method is still capable of consistently separating and accurately quantifying a co-eluting impurity peak from the active ingredient peak.
Drug GMP Report