FDA WARNING_LETTER - La Vita Compounding Pharmacy, LLC - June 08, 2018

The FDA inspected La Vita Compounding Pharmacy, LLC from June 4-8, 2018, identifying serious deficiencies in sterile drug production and failure to meet Section 503A conditions of the Federal Food, Drug, and Cosmetic Act (FDCA). The firm voluntarily ceased sterile production on June 22, 2018, and recalled all sterile drug products within expiry on June 25, 2018. Violations included compounding drug products using bulk substances (grape seed oil, green tea extract, hyaluronic acid, and dimethylaminoethanol bitartrate) that are not eligible for 503A exemptions, as they lack USP/NF monographs, are not FDA-approved drug components, and are not on the 503A bulks list. This renders these products unapproved new drugs, misbranded under 21 U.S.C. § 352(f)(1) due to inadequate directions for use, and subject to CGMP requirements. Additionally, drug products intended to be sterile were prepared under insanitary conditions, leading to adulteration under 21 U.S.C. § 351(a)(2)(A). FDA found the firm's proposed corrective actions, particularly regarding cleaning agents for non-sterile hazardous drug production equipment, inadequate, raising concerns about cross-contamination. FDA strongly recommends a comprehensive assessment of operations, including aseptic processing, with assistance from a third-party consultant. The firm must respond within fifteen working days, detailing corrective actions and preventive measures, or face potential legal action.