Family Pharmacy of Statesville, Inc. – FDA Warning Letter, Feb 12, 2020

On November 6, 2020, the FDA issued a Warning Letter to Family Pharmacy of Statesville, Inc., following an inspection from February 3-12, 2020. The inspection revealed the firm produced drug products that failed to meet Section 503A of the FDCA conditions for exemption from certain provisions, including CGMP, adequate labeling, and FDA approval. Specifically, the firm did not receive valid prescriptions for individually-identified patients for a portion of its compounded drug products.

The FDA investigator noted serious deficiencies in sterile drug product production, leading to adulterated drugs under Section 501(a)(2)(A) of the FDCA due to insanitary conditions. Violations included: not using a sporicidal agent in ISO 5 areas; re-using unverified sterile bottles; improper storage of sterile wipes; inadequate cleaning for hazardous drugs; facility design allowing influx of lesser quality air into higher quality areas (e.g., unclassified area to sterile production via pass-through, anteroom lacking HEPA filtration); media fills not performed under challenging conditions; use of materials not verified for endotoxin contamination; and failure to confirm water quality for non-sterile products.

Furthermore, the ineligible drug products were adulterated under Section 501(a)(2)(B) of the FDCA due to significant CGMP violations, including failure to establish adequate cleaning/disinfecting systems (21 CFR 2