FDA Cites API Maker for Data and Label Discrepancies

The FDA issued Form 483s to two international API makers, citing recordkeeping failures and incomplete labeling.

A January 2016 inspection of Cosma’s facility in Ciserano, Italy turned up inadequate maintenance of testing data.

The facility allowed deletion or overwriting of data for several of its chromatography and spectroscopy systems, and it lacked procedures for reviewing audit trails. The FDA also faulted Cosma for failing to keep chromatographic data earlier than 2011 and for its practice of destroying raw equipment calibration data.