FDA WARNING_LETTER - Delta Kozmetik Sanayi Ve Ticaret-Selim Yesil - July 20, 2021

The FDA issued a Warning Letter to Delta Kozmetik Sanayi Ve Ticaret-Selim Yesil (FEI 3010166780) on July 8, 2021, following the detention and refusal of admission of their hand sanitizer product, (b)(4), at the U.S. border. FDA testing revealed the product, labeled to contain (b)(4)% ethyl alcohol, only contained an average of 59% v/v ethanol, falling below the labeled strength and the CDC's recommended minimum of 60%. This constitutes adulteration under section 501(c) of the FD&C Act.

Furthermore, the subpotency and deficiencies in the firm's provided test methods for incoming active pharmaceutical ingredient (ethanol) and finished product demonstrate a failure of the quality assurance system to comply with Current Good Manufacturing Practice (CGMP) requirements, leading to adulteration under section 501(a)(2)(B) of the FD&C Act. Specifically, the firm's methods lacked appropriate identity testing for ethanol, methanol testing (21 CFR 211.84), and adequate finished product assay testing (21 CFR 211.165).

The FDA placed all drugs from this firm on Import Alert 66-78 on May 17, 2021. The firm is required to provide a detailed investigation into