FDA WARNING_LETTER - Civic Center Pharmacy, Inc. - October 09, 2014

On August 20, 2015, the FDA issued a Warning Letter to Civic Center Pharmacy following an inspection from September 10 to October 9, 2014. The inspection revealed several violations of the Federal Food, Drug, and Cosmetic Act (FDCA).

Key violations include: 1. **Lack of Valid Prescriptions:** The pharmacy was producing drug products without receiving valid prescriptions for individually-identified patients, which disqualifies them from exemptions under FDCA Section 503A. 2. **Domperidone Production:** The firm produced domperidone products, which are not subject to an applicable USP/NF monograph, are not components of FDA-approved human drugs, and are not on the Secretary's list for compounding under 503A(b)(1)(A)(i)(III). This also makes them ineligible for 503A exemptions. 3. **Insanitary Conditions for Sterile Products:** Serious deficiencies were observed in sterile drug product production, including an operator's arm moving over open vials during filling, failure to use sterile disinfectants for the ISO 5 area, and lack of studies to demonstrate adequate protection by the hood in the ISO 5 area. These conditions render products adulterated under FDCA Section 501(a)(2)(A). 4. **CGMP Violations:** For drugs produced without individual prescriptions, the firm is subject to CG