PENMIX LTD – FDA 483, May 29, 2026

PENMIX LTD, a sterile drug manufacturer in Cheonan, Korea, was cited for multiple significant deficiencies during an FDA inspection. Observations included inadequate aseptic process validation, failure to follow aseptic procedures, deficient environmental monitoring, and an inadequate visual inspection program. Additionally, the firm failed to maintain complete batch production records, lacked proper controls over computerized systems, and did not thoroughly investigate discrepancies or batch failures, indicating systemic quality control issues.