FDA 483 - Alaunus Pharmaceutical, LLC - November 16, 2012

On October 19, November 7, and November 16, 2012, the FDA inspected Alaunus Pharmaceutical LLC, an API Repacker located at 687 Waverly Street, Framingham, MA 01702. The inspection, conducted by Debra M. Emerson, Investigator, identified four observations.

The firm repacks bulk APIs including Fentanyl, Morphine Sulfate, Methadone, Hydromorphone, and Bupivicaine into 3MW containers. A key observation was the lack of testing to ensure these containers are not reactive, additive, or absorptive with the APIs.

The stability program for repackaged APIs was found deficient. Only the first lot of each API was placed on stability, and the firm failed to place one lot of each API on stability for each calendar year of repackaging. Specifically, for Bupivicaine API lot 10-AA-001, the May 2012 month time point pull was missed, and data is still unavailable.

Master production records were deficient as not all critical steps were defined. For example, the step of labeling the outer bag after the API is filled, sealed in a bag, and then placed into another sealed bag, was not documented.

Finally, batch production records lacked documentation. There was no record of which operator added the outer label to the (b)(4) bag, nor was there documentation of verification for