FDA EIR - Ascent Pharmaceuticals Inc - February 21, 2018

An FDA inspection of Ascent Pharmaceuticals, Inc., a generic prescription drug manufacturer in Central Islip, NY, was conducted from February 6 to February 21, 2018. This comprehensive inspection, guided by various Compliance Program Guidance Manuals (CPGM) for drug manufacturing, quality reporting, field alert reporting, and pre/post-approval inspections, covered the firm's operations across all six quality systems following a recent facility relocation.The inspection concluded without any formal FDA-483 observations, indicating overall compliance. However, five minor verbal deficiencies were noted and communicated to management. These included inadequate review of executed batch manufacturing records, an inappropriate adjust limit for the trailing edge seam thickness of Dutasteride Capsules, a late submission of one annual product report, an inadequate display value for an eyepiece used to measure tablet orifice diameter, and insufficient timer calibration on a dissolution sampling station. The inspection also reviewed Drug Quality Reporting System reports, Field Alert Reports, a post-approval assignment, and a drug product recall for Oxycodone HCl Tablets due to a labeling issue, identifying no deficiencies in these specific areas.The main required actions involve management addressing the verbally communicated observations. The inspection ultimately resulted in a recommendation for district approval of ANDA 211009 for Methylphenidate Hydrochloride Extended Release Tablets, with certain equipment qualifications related to the relocation to be monitored during subsequent routine inspections.