FDA WARNING_LETTER - Eastern Pharmacy, Inc. - February 04, 2014

On October 29, 2014, the FDA issued a Warning Letter to Eastern Pharmacy, Inc. following an inspection from January 30 to February 4, 2014. The inspection was prompted by adverse events in at least 37 patients who received intravitreal injections of Avastin or Lucentis repackaged by the firm.

The FDA found significant deficiencies in the production of sterile drugs, leading to adulteration charges under section 501(a)(2)(A) of the FDCA. Violations included the failure to use a functional laminar flow hood (it was "not turned on" or "functional" and used only as a flat surface) and the lack of separation between the sterile drug processing area and the common pharmacy area. Furthermore, the firm repackaged Avastin and Lucentis by completely removing the rubber stoppers from sterile, preservative-free vials, exposing contents to an uncontrolled environment. These practices placed sterile drugs at considerable risk of microbial contamination, as highlighted by the adverse events.

Eastern Pharmacy ceased sterile product production on January 13, 2014, and stated they do not intend to resume. If they do resume, the FDA strongly recommends a comprehensive assessment of operations, including facility design, procedures, personnel, processes, and systems, possibly with a third-party consultant. The firm must notify the FDA within fifteen working days of receipt of the letter regarding steps taken or confirmation