Colonial Dames Company, Ltd
FDA issued a warning letter to Colonial Dames Company, Ltd (Commerce, CA) following a April 2023 inspection that found significant CGMP violations and unapproved new drug marketing for its 'oxygenetix® Oxygenating Foundation Acne Control' and a redacted companion product. The products were marketed with drug claims—including acne treatment, anti-inflammatory, antimicrobial, and time-release salicylic acid efficacy claims—without FDA approval and in non-conformance with the OTC Topical Acne Monograph M006. The facility also had repeat CGMP deficiencies (unclean equipment, unvalidated processes, inadequate quality unit oversight) dating back to 2015 inspections, and failed to properly list the drug products with FDA. FDA warned that failure to correct violations may result in seizure, injunction, or withholding of export certificates and new application approvals.
Flagged claims (7)
anti-inflammatory . . . antimicrobial
Oxygenating Acne Control contains 2% time-release salicylic acid . . . Oxygenetix Acne Control gets applied to the surface epidermis of the skin where it has the highest concentration, then it diffuses over time throughout the skin. This time release system works to ensure the salicylic acid kills acne-causing bacteria and reduces inflammation throughout the day.
TREATS ACNE, HELPS PREVENT DEVELOPMENT OF NEW ACNE BLEMISHES
Acne Control . . . ceravitae pro-oxygen complex . . . DRUG FACTS . . . USES: . . . TREATS ACNE, HELPS PREVENT DEVELOPMENT OF NEW ACNE BLEMISHES
Oxygenating Acne Control Foundation clears not causes acne, giving you confidence even on your worst skin days. And the aloe vera base, instead of water or oils that attract bacteria to your skin, is antibacterial and soothing.
Ceravitae allows your skin to absorb more oxygen, stimulating skin cell production and helping to heal.
Ceravitae® is the Oxygenetix patented hero ingredient, a potent derivative from Saccharomyces Lysate, a yeast compound with pro-healing properties. Ceravitae® promotes oxygen uptake to skin cells which in turn accelerates tissue growth.
Required actions (5)
After you receive this letter, respond to this office in writing within 15 working days. Specify what you have done to address any violations and to prevent their recurrence.
Correct any violations promptly. Failure to promptly and adequately address this matter may result in regulatory or legal action without further notice including, without limitation, seizure, and injunction.
Failure to promptly and adequately address this matter may result in regulatory or legal action without further notice including, without limitation, seizure, and injunction.
The FDA may withhold approval of new applications or supplements listing your firm as a drug manufacturer until any violations are completely addressed and we confirm your compliance with CGMP.
We may re-inspect to verify that you have completed corrective actions to address any violations.
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