FDA WARNING_LETTER - Ardil Comercial S.R.L. - June 16, 2021

The FDA issued a Warning Letter to Pastora Elida (Ardil Comercial S.R.L.) after their Alcohol Isopropilico Hand Sanitizer Limar was detained at the U.S. border. FDA testing revealed the product, labeled 70% Isopropyl Alcohol (IPA), contained only 48% IPA and an undeclared 16% ethanol. This constitutes adulteration under section 501(d)(2) of the FD&C Act due to active ingredient substitution, and indicates a failure of the firm's quality assurance system to comply with Current Good Manufacturing Practice (CGMP) requirements (501(a)(2)(B)). Deficiencies include inadequate test methods for incoming API and finished product (21 CFR 211.84, 211.165) and an insufficient investigation. The hand sanitizer is an unapproved new drug, violating section 505(a) and 301(d), as it's not GRASE and doesn't conform to the Tentative Final Monograph or temporary COVID-19 policies. The product is also misbranded under several FD&C Act sections. Labeling is false/misleading (502(a)) due to incorrect IPA concentration and undeclared ethanol. It fails dual language labeling requirements (502(c), 21 CFR 201.15) by lacking a Spanish "Drug Facts" panel. The container, resembling a water bottle, is misleading (502(i)(1)), posing an ingestion risk. The label lacks a domestic address/phone for adverse event reporting (502(x)), and the product doesn't comply with 505G marketing requirements (502(ee)). FDA recommends a qualified CGMP consultant. All firm drugs are on Import Alert 66-78. The firm must respond within 15 working days with an updated investigation, raw material lists, batch records, and a commitment to test for methanol.