Monarch PCM, LLC – FDA Warning Letter, Aug 20, 2021

The FDA inspected Monarch PCM, LLC from June 7 to August 20, 2021, identifying significant Current Good Manufacturing Practice (CGMP) violations, rendering their drug products adulterated. The firm manufactures Hydroquinone USP, 4% Skin Bleaching Cream, Sodium Sulfacetamide 10% Wash, Sodium Sulfacetamide 10% and Sulfur 5% Cleanser, and Selenium Sulfide 2.25% Shampoo, which are cited as unapproved new drugs. Additionally, Hydroquinone USP 4% Skin Bleaching Cream and Selenium Sulfide 2.25% Shampoo are not properly listed with the FDA, making them misbranded.

Key violations include: 1. **Inadequate Investigations (21 CFR 211.192):** Failure to thoroughly investigate out-of-specification (OOS) results for drug components and finished products, including microbial contamination (Burkholderia cepacia complex - BCC). Investigations were insufficient, often invalidating OOS results based on retesting without scientific justification, and failing to implement adequate corrective and preventive actions (CAPAs). 2. **Inappropriate Equipment Design and Maintenance (21 CFR 211.63):** Water systems and manufacturing equipment are not designed, cleaned, or maintained appropriately, contributing to persistent objectionable microorganism findings. 3. **Quality Control Unit Failures (21 CFR 211.22):** The Quality Unit