FDA 483 - Wells Pharma of Houston LLC - June 17, 2021

This FDA Form 483 document details observations from an inspection concerning the manufacturing of sterile, injectable drug products. The facility's procedures designed to prevent microbiological contamination of these products were found to be inadequate, not established, written, or followed.

A specific critical finding relates to the maintenance of unidirectional airflow within the ISO 5 laminar air flow workbenches, where sterile compounding occurs. During a review of the smoke study dated 2/4/2021 for Laminar Air Flow Workbench #EQ-HOU-LAFW-067, it was observed that "first air" (the initial, cleanest air) was striking a stainless steel shelf inside the ISO 5 hood. This occurred before the air swept down across aseptic connections, and subsequently, the air recirculated beneath the same stainless steel shelf. This indicates a failure to maintain proper unidirectional airflow, which is crucial for preventing contamination in sterile environments. The observation implies a deficiency in the facility's quality system and manufacturing controls related to aseptic processing and environmental monitoring.