CMC Biologics – FDA EIR, Apr 20, 2017

An FDA surveillance inspection of CMC Biologics, Inc. in Bothell, Washington, was conducted from April 12-20, 2017. The inspection, performed under the Team Biologics FY' 2017 work plan and Compliance Policy Guide Manual 7345.848, primarily focused on the company's Quality and Production Systems, with limited review of the Laboratory System. The company is a contract manufacturer of licensed bulk biological products, including (b)(4) Recombinant Coagulation Factor. The inspection revealed several significant compliance issues, which were detailed in a Form FDA-483. Key violations included incomplete conclusions and follow-up actions in deviation investigations, particularly for product (b)(4) bulk drug substance, where product disposition or comprehensive impact assessments were missing. Furthermore, a Corrective and Preventive Action (CAPA) related to an environmental control observation lacked a required six-month effectiveness check and was not integrated into the relevant sanitization procedure. A recurring pattern of operator documentation errors over a six-month period also failed to trigger a formal CAPA plan. Finally, a storage freezer for finished bulk drug substance lacked clear labeling indicating its "Released" or "Quarantine" status. CMC Biologics, Inc. acknowledged the observations and committed to corrective actions. The company was directed to submit a written response to the FDA within 15 business days outlining their plans to address these identified deficiencies.