FDA EIR - Chartwell Pharmaceuticals Carmel LLC - November 02, 2015

An FDA inspection of Silarx Pharmaceuticals, Inc. in Carmel, NY, was conducted from October 19 to November 2, 2015. This comprehensive inspection, guided by CPGM 7356.002 for drug manufacturing and CPGM 7352.832 for Pre-Approval Inspections (specifically ANDA 207236 for Memantine HCl Tablets), assessed the company's compliance with current Good Manufacturing Practices (cGMP). The inspection identified six significant observations, detailed in an FDA-483. Key issues included: inadequate review of executed batch records for accuracy, a lack of authority within the quality control unit to assure production record integrity, and deficiencies in microbiological testing media preparation, storage, and growth promotion testing. Furthermore, Silarx was cited for not conducting stability chamber mapping studies under full-load conditions, insufficient calibration and qualification of manufacturing and packaging equipment, and inadequate cleaning validation studies (a recurring issue from a previous inspection). Specifically for ANDA 207236, discrepancies were found between documented and actual packaging equipment, and critical equipment was uncalibrated for in-process checks. At the closeout meeting, Silarx management acknowledged the observations and provided a commitment letter, promising a written response within 15 business days. Consequently, the FDA recommended a "Withhold" for ANDA 207236, pending satisfactory resolution of the identified deficiencies and submission of corrective actions.