FDA WARNING_LETTER - Colonial Dames Company, Ltd - April 12, 2023

The FDA inspected Colonial Dames Company, Ltd. (FEI 2011035) in Commerce, CA, from April 4-12, 2023, identifying significant Current Good Manufacturing Practice (CGMP) violations, rendering their drug products adulterated. The "oxygenetix® (b)(4)" and "oxygenetix® Oxygenating Foundation Acne Control" products were cited as unapproved new drugs and misbranded. The company also failed to fulfill drug listing obligations.

Key violations include: 1. **Inadequate Production and Process Controls (21 CFR 211.100(a)):** Manufacturing records lacked critical parameters (e.g., equipment ID, mixing speeds/times, component addition rates), and process validation documentation was absent. 2. **Insufficient Equipment Cleaning and Maintenance (21 CFR 211.67(a) and (b)):** Cleaning procedures lacked validation, records were not maintained, and equipment/areas were unclean, a repeat observation from 2015 and 2021 inspections. 3. **Unsuitable Equipment Design and Maintenance (21 CFR 211.63):** The water system used for drug manufacturing was not qualified, lacked monitoring, and showed increasing rust, despite prior commitments to use qualified vendor water. 4. **Failure of Quality Control Unit (21 CFR 211.