FDA WARNING_LETTER - Compounded Solutions in Pharmacy, LLC - March 03, 2017

The FDA inspected Compounded Solutions in Pharmacy, LLC from February 22 to March 3, 2017, identifying serious deficiencies in sterile drug production and failure to meet Section 503A conditions, posing patient risks. The firm's drug products were found to be adulterated, unapproved new drugs, and misbranded. Specific violations included: not receiving valid prescriptions for individually-identified patients for a portion of products; using bulk drug substances (rose geranium oil, chloroacetic acid, m-cresol) not eligible for 503A exemptions; preparing sterile products under insanitary conditions (e.g., non-sterile attire in ISO 5, unsealed ceiling tiles in ISO 7); and significant CGMP violations. CGMP deficiencies included failure to establish procedures for preventing microbiological contamination (21 CFR 211.113(b)), inadequate aseptic area ceilings (21 CFR 211.42(c)(10)(i)), improper equipment cleaning (21 CFR 211.67(a)), and inadequate environmental monitoring (21 CFR 211.42(c)(10)(iv)). Additionally, the firm lacked FDA-approved applications for ineligible products (Section 505(a)) and these products were misbranded due to lacking adequate directions for use (Section 502(f)(1)). While the firm's plan to discontinue "office use only" compounding was noted, FDA could not fully evaluate other corrective actions (e.g., ceiling tile sealing, caulking repairs) due to insufficient documentation. FDA strongly recommends a comprehensive operational assessment, particularly for aseptic processing, with a third-party consultant. Failure to promptly correct violations may lead to legal action, including seizure and injunction.