Forest Pharmaceuticals, Inc – FDA EIR, May 20, 2016

An FDA inspection of Forest Pharmaceuticals Inc., Cincinnati, OH, was conducted from May 16-20, 2016. This comprehensive Good Manufacturing Practices (GMP) inspection focused on prescription drug manufacturing, adhering to CP 7356.002, "Drug Manufacturing Inspections," and employed a quality systems approach.

The inspection noted that objectionable conditions identified in a previous October-November 2012 inspection had been corrected. These prior issues included: inadequate review of unexplained discrepancies (specifically, a delayed laboratory investigation), a quality control unit failing to follow procedures (incorrect package quantity for leak test), and insufficient inspection of packaging facilities before use (tablets found during pre-packaging). Forest Pharmaceuticals had implemented corrective and preventive actions (CAPAs) and updated relevant standard operating procedures to resolve these.

During the current 2016 inspection, no previous issues were outstanding. The primary new observation concerned an incorrect potency unit (displayed as "%" instead of "µg/mg") for full strength thyroid powder in the master formula application software. Management provided a satisfactory calculation proof, and the firm promptly initiated a CAPA (Record#94409) to address and prevent recurrence of this data entry error in the software's column tab. No refusals were encountered, and no samples were collected, indicating generally compliant operations with one minor, promptly addressed software issue.