Home Care Pharmacy of Palm Coast, Inc. – FDA Warning Letter, May 25, 2016

From May 17-25, 2016, an FDA inspection of Home Care Pharmacy of Palm Coast, Inc. revealed serious deficiencies in sterile drug product production and failure to meet Section 503A of the FDCA. The firm did not receive valid prescriptions for individually-identified patients for a portion of compounded drugs, rendering them ineligible for exemptions from CGMP, adequate labeling, and FDA approval.

Violations included insanitary conditions for sterile products, such as improper cleaning agents (no sporicidal agent, lack of contact times), use of nonsterile gloves, and absence of HEPA filters in the ISO 8 area. These conditions caused drug products to be adulterated under FDCA Section 501(a)(2)(A).

Furthermore, significant CGMP violations (21 CFR Parts 210 and 211) were observed, including failure to establish adequate cleaning/disinfection systems (211.42(c)(10)(v)), ensure HEPA-filtered air in aseptic areas (211.42(c)(10)(iii)), monitor environmental conditions (211.42(c)(10)(iv)), conduct sterility testing for sterile products (211.167(a)), and validate aseptic/sterilization processes (211.113(b)). These violations also caused products to be adulterated under Section 501(