FDA WARNING_LETTER - U.S. Continental Marketing, Inc. - October 30, 2018

The FDA inspected U.S. Continental Marketing, Inc. from October 25-30, 2018, revealing significant Current Good Manufacturing Practice (CGMP) violations for finished pharmaceuticals, rendering their drug products adulterated under 21 U.S.C. 351(a)(2)(B). The primary deficiency identified was the firm's failure to establish an adequate quality control unit (QU) with the responsibility and authority to approve or reject all components, materials, and drug products, as required by 21 CFR 211.22(a). Specifically, the QU failed to assure the sterility of contract-manufactured ophthalmic drug products, neglecting to ensure the contract manufacturer could sterilize containers and closures or possessed adequate sterile manufacturing facilities. This systemic failure resulted in FDA laboratory confirmation of Bacillus spp. and high particulate matter contamination in multiple lots, leading to a product recall. Although the firm stated an intent to cease drug product involvement and not seek FDA registration, they failed to propose specific corrective actions. The FDA emphasizes that contractors are extensions of the manufacturer, responsible for drug quality. The firm must promptly correct all violations, investigate root causes, and prevent recurrence. A written response detailing corrective actions or a completion schedule is required within 15 working days. Failure to comply could result in legal action, withheld drug approvals, and refusal of export certificates.