FDA Finds Major CGMP and Compliance Violations at Medical Chemical Corporation Facility

During an inspection from February 12–18, 2025, at Medical Chemical Corporation’s Torrance, California site, the FDA identified multiple violations of Current Good Manufacturing Practice (CGMP) regulations, rendering certain drugs adulterated under U.S. law.

Key findings include:

• Testing Failures: No identity testing of active ingredients such as ethanol and glycerin; reliance on unverified supplier COAs; lack of methanol, DEG, and EG testing for high-risk ingredients.
• Water System Deficiencies: Unvalidated system, absence of TOC testing, microbial contamination after maintenance, and no retrospective testing of released batches.
• Quality Oversight Gaps: Incomplete data, inadequate documentation, and insufficient quality department authority.

Additionally, “MED CHEM Tincture Green Soap” was deemed an unapproved, misbranded drug, while registration data for “Tincture Green” and “Isopropyl Alcohol” were outdated, violating FDA listing rules.

The FDA requires corrective actions, including supplier verification, water system validation, risk assessments, recalls if necessary, and strengthened quality assurance processes.

27-08-2025