FDA Warning Letter with a diverse List of Deficiencies

During an inspection conducted from February 12 to 18, 2025, at the production facility of Medical Chemical Corporation (Torrance, California), the FDA identified serious violations of CGMP (Current Good Manufacturing Practice) requirements. These violations result in the affected drugs being considered adulterated under US law. In addition, one product (“MED CHEM Tincture Green Soap”) was found to be an unapproved new drug and misbranded.

1. CGMP Violations

• No identity testing was performed for each batch of each active ingredient (e.g., ethanol, glycerin).
• Supplier certificates (COAs) were used without verifying their reliability.
• Ethanol was not tested for methanol – a significant safety risk.
• Glycerin and other high-risk ingredients were not tested for diethylene glycol (DEG) or ethylene glycol (EG).

b. Inadequate control of the water system (21 CFR 211.100):

• The water used was not validated according to USP standards (e.g., no TOC testing) .
• Microbial contamination was detected after maintenance work.
• Detailed plans for system validation are missing and no retrospective tests were performed on products that had already been released.

c. Weaknesses in quality assurance (21 CFR 211.22):

• The quality department does not have adequate oversight of manufacturing and testing operations.
• Important manufacturing and testing data is missing or incompletely documented.

2. Unapproved and mislabeled Drug:

• “MED CHEM Tincture Green Soap” contains ethanol (30%) and is advertised as an antiseptic, but does not meet the FDA's requirements for OTC antiseptics.
• The product does not comply with any monograph and has not been approved by the FDA – it is therefore an unapproved, mislabeled drug.

3. Violations of Drug Registration and Listing Requirements (21 CFR Part 207):

• The products “Tincture Green” and “Isopropyl Alcohol” were not properly updated or certified in the FDA database, making them misbranded.

The FDA emphasizes that current registration and listing data are critical for surveillance, traceability, and patient safety.

FDA Requirements:

• Comprehensive review of supplier management and testing procedures.
• Validation and ongoing monitoring of the water system.
• Risk assessments, recalls, and evidence of the safety of the affected products.
• Correction of all deficiencies, including documentation, testing methods, and quality assurance systems.

In addition, the FDA recommendsa GMP consulting. All details about the deficiencies found can be found directly in the FDA Warning Letter .