Cosmetic Solutions, LLC – FDA Warning Letter, Sep 21, 2023

On May 31, 2024, the FDA issued a Warning Letter to Cosmetic Solutions, LLC, following an inspection from September 12-21, 2023. The inspection revealed significant Current Good Manufacturing Practice (CGMP) violations, rendering the firm's drug products adulterated under 21 U.S.C. 351(a)(2)(B). Additionally, the (b)(4), and (b)(4) drug products were identified as unapproved new drugs, violating 21 U.S.C. 355(a).

Key violations included the failure to establish adequate written responsibilities and procedures for the quality control unit (21 CFR 211.22(d)), leading to insufficient oversight of OTC drug manufacturing. The firm also failed to establish adequate written procedures for production and process control (21 CFR 211.100(a) and (b)), specifically regarding a lack of purified water system qualification and validation, and inadequate cleaning validation. The water system repeatedly failed microbial testing, and batches were released despite this.

The (b)(4), and (b)(4) products were deemed "new drugs" because their labeling claims indicated intended uses for disease treatment or affecting body structure/function, without being generally recognized as safe and effective (GRASE) or having FDA approval. The (b)(4) and (b)(4)