Endo Gets 483 Over Laboratory Controls

February 11, 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.

Endo’s laboratory controls presume that all potentially high or poorly integrated impurity peaks, obtained from a method redacted in the letter, are the result of an unreliable or failing HPLC column, the form adds. But this excludes the possibility that the column is reliable and would have provided legitimate results if the analysis was completed.
Drug GMP Report