FDA WARNING_LETTER - Farmville Discount Drug, Inc. DBA Best Value Drug - November 17, 2017

The FDA inspected Farmville Discount Drug, Inc., dba Best Value Drug, from November 13-17, 2017, and found serious deficiencies in sterile drug product production, putting patients at risk. The firm failed to meet Section 503A of the FDCA conditions for exemption from CGMP, labeling, and FDA approval requirements.

Violations included producing Colloidal Silver, an oral inhalation solution, with non-pharmaceutical grade ingredients in an unclassified environment. Poor aseptic practices were observed, such as technicians blocking first-pass air, failing to change/sanitize gloves, contacting ISO-5 surfaces with non-sterile gowns, and manipulating sterile gloves with bare hands. The firm used non-sterile cleaning agents and wipes in the ISO 5 area and failed to perform adequate dynamic smoke studies. Facility design was inadequate, with vents connecting to unclassified areas and gaps in cleanroom walls.

These conditions caused drug products to be adulterated under Section 501(a)(2)(A) of the FDCA. Ineligible drug products were also subject to CGMP regulations (21 CFR Parts 210 and 211), with significant violations including failure to establish and follow procedures to prevent microbiological contamination (21 CFR 211.113(b)). The ineligible drug products were also misbranded under Section 502(f)(1) of the FDCA because adequate directions for use could not