Skyless LLC – FDA Warning Letter, May 16, 2022

The FDA issued a Warning Letter to Skyless, LLC, following an inspection from May 2 to May 16, 2022, at their Ponce, Puerto Rico drug manufacturing facility. The letter identifies significant Current Good Manufacturing Practice (CGMP) violations, rendering their drug products adulterated under 21 U.S.C. 351(a)(2)(B). Additionally, three specific products—"X-PASMO® ARTHRITIS FORMULA PAIN RELIEF OINTMENT," "X-PASMO® MUSCULAR FORMULA MUSCULAR PAIN RELIEF & MASSAGE RUB OINTMENT," and "X-PASMO® UNGUENTO MANTECA DE UBRE ANALGESICO TOPICO"—are cited as unapproved new drugs (21 U.S.C. 355(a)) and misbranded (21 U.S.C. 352(ee) and 352(c)). CGMP deficiencies include failure to perform appropriate laboratory determination of satisfactory conformance to final specifications for drug products prior to release (21 CFR 211.165(a)), failure to test each component for identity and validate supplier analyses (21 CFR 211.84(d)(1) and (d)(2)), and an inadequate Quality Control Unit failing to ensure CGMP compliance and product specifications (21 CFR 211.22). The firm's responses to these CGMP issues were deemed inadequate, lacking detailed procedures and a supplier qualification plan. The X-PASMO products are considered unapproved new drugs because they are not generally recognized as safe and effective (GRASE) and do not conform to the conditions of use specified in the external analgesic Tentative Final Monograph (TFM) or subsequent final administrative orders. Specific issues include incorrect active ingredient dosages (camphor in Arthritis Formula, methyl salicylate in Unguento Manteca de Ubre) and unapproved claims (e.g., reducing inflammation, anti-inflammatory, antispasmodic, stress reduction, respiratory benefits). The Muscular Formula also contains eucalyptus oil, which is not GRASE. Furthermore, "X-PASMO® UNGUENTO MANTECA DE UBRE ANALGESICO TOPICO" is misbranded due to incomplete bilingual labeling (21 U.S.C. 352(c)), and all three products are misbranded under 21 U.S.C. 352(ee) for non-compliance with 505G requirements. Finally, all three products were never listed with the FDA, violating 21 U.S.C. 360(j)(1) and 21 CFR 207.41, rendering them misbranded under 21 U.S.C. 352(o). The FDA strongly recommends engaging a qualified CGMP consultant. The firm must respond within 15 working days, detailing corrective actions and a prevention plan. Failure to address these violations may lead to regulatory actions, including seizure, injunction, withholding of export certificates, and disapproval of new applications.