FDA EIR - AVEVA Drug Delivery Systems, Inc. - September 01, 2023

An FDA inspection of AVEVA Drug Delivery Systems, Inc. in Miramar, FL, was conducted from August 28 to September 1, 2023. This comprehensive current Good Manufacturing Practice (cGMP) inspection, performed under Compliance Program 7356.002 for drug manufacturing, identified two main deficiencies on a Form FDA 483, Inspectional Observations. The first observation cited insufficient control over label and labeling materials, specifically a broken gate that left a storage area freely accessible to unauthorized personnel for several months, violating 21 CFR 211.122(d). The second violation involved inadequate washing and toilet facilities, noting a lack of readily available hot water in bathrooms near manufacturing and laboratory areas, contrary to 21 CFR 211.52. Additionally, a verbal observation highlighted that the company's "Product Quality Complaints" procedure (SOP-01.128-AVE) lacked definitions for "serious" or "unexpected" adverse events. Company management, led by Vice President of Operations Mr. Wilfredo NMI Diaz Jr., acknowledged the findings, committed to making corrections, and promised to provide a formal response within fifteen business days. During the inspection, the firm initiated voluntary corrections, including repairing the broken gate and addressing the hot water issue. The FDA cautioned that uncorrected issues could lead to regulatory sanctions, including seizure, injunctions, or civil penalties under the FD&C Act. The inspection covered transdermal patches and sublingual films, and notably, the firm is currently under new management (DifGen Pharmaceuticals) and in a transitional agreement with its former owner, Apotex Inc.