Wells Pharmacy, Inc – FDA 483, Apr 27, 2018

An FDA inspection of a pharmaceutical manufacturing facility, which produces implantable hormonal pellets, uncovered significant Current Good Manufacturing Practice (cGMP) violations. The inspection, evidenced by observations dating from 2017 through April 2018, revealed a profound lack of quality oversight and procedural adherence. The primary issue was the Quality Unit's systematic failure to review and approve production and control records, resulting in the release of drug product batches with documented out-of-specification (OOS) results for environmental monitoring, including microbial contamination from personnel and air quality issues. Further critical violations include the Quality Control unit's lack of understanding regarding their responsibilities in reviewing critical documents and data. The facility demonstrated deficient aseptic processing areas with sporadic cleaning, use of inappropriate equipment in cleanrooms, and poor structural maintenance (e.g., torn chairs, excess caulking). Essential validation studies, such as cleaning efficacy and hold times, were absent, and environmental monitoring methods were inadequate. Additionally, equipment calibration procedures were not followed, with critical devices like air samplers being out of calibration for months while in use. Batch records showed deficiencies in documentation and verification. To address these systemic failures, the firm must implement robust corrective and preventive actions across all operations. This includes strengthening the Quality Unit's competence and oversight, validating all critical processes, improving environmental controls and cleaning regimens, ensuring proper equipment maintenance and calibration, and maintaining accurate and timely batch documentation to ensure product quality and patient safety.