FDA EIR - Epic Pharma, LLC - February 01, 2019

An FDA inspection of Epic Pharma, LLC, a manufacturer of prescription and over-the-counter human drugs in Laurelton, NY, was conducted from January 22 to February 1, 2019. This comprehensive inspection, performed under the FY 2019 Tier C Drug cGMP workplan and relevant CPGMs, covered the company’s Quality, Materials, Facilities and Equipment, and Packaging and Labeling systems. The inspection also addressed a post-approval review for Oxycodone Hydrochloride Tablets.

The inspection concluded with the issuance of a six-item FDA 483, identifying significant deficiencies. These included the failure to validate manufacturing processes, inadequate examination and testing of in-process and finished product samples to ensure adherence to specifications (notably concerning low-fill Oxycodone HCl bottles), insufficient cleaning intervals for equipment, lack of detailed procedures for component handling, improper drug product storage conditions, and inadequate mechanical equipment calibration programs. Additionally, three verbal observations were discussed, highlighting overdue SOP reviews, absence of quality agreements with API suppliers, and a lack of data supporting blend and core tablet hold times.

A product recall (D-0297-2019) for Estradiol Tablets, initially Class III and reclassified to Class II, was also reviewed. The recall, due to a foreign tablet from a contract manufacturer, necessitated an expanded retail-level notification. Management acknowledged the observations and committed to providing a written response within 15 business days. The company's prior corrective actions from a 2017 inspection were deemed adequate. Follow-up on specific corrective actions and field alert reports is required for future inspections.