Wedgewood Connect, LLC – FDA 483, Jul 3, 2025

The FDA conducted an inspection of Wedgewood Connect, LLC, an outsourcing facility located at 17 Great Oaks Blvd, San Jose, CA, from June 23 to July 3, 2025. This inspection revealed several critical compliance issues under the regulatory framework of the Federal Food, Drug, and Cosmetic Act (FD&C Act).

Key violations identified include inadequate written procedures for production and process controls, particularly in environmental monitoring and sample collection, which may lead to false negative results. The firm"s procedures failed to ensure comprehensive surface sample collection within critical zones, potentially compromising product sterility. Additionally, training deficiencies were noted, as employees were not adequately trained to identify defects during visual inspections of drug products.

The inspection also highlighted deficiencies in the aseptic processing areas, particularly in monitoring environmental conditions. Notably, a validation study excluded critical equipment, undermining the firm"s ability to ensure a controlled manufacturing environment. Furthermore, the stability program did not include testing in the marketed container-closure system, following a supplier change, raising concerns about product quality throughout its shelf life.

Moreover, procedures to prevent microbiological contamination were found lacking, as evidenced by the release of contaminated drug batches despite confirmed bacterial presence. These issues collectively indicate significant lapses in maintaining sterile conditions and ensuring product safety.

Wedgewood Connect, LLC is required to address these observations promptly by revising procedures, enhancing employee training, and ensuring robust environmental monitoring and stability testing to comply with FDA regulations and ensure the safety and efficacy of their drug products.