FDA EIR - Surface Dynamics LLC - September 26, 2018

Surface Dynamics LLC, a contract manufacturer of medical device coatings in Cincinnati, Ohio, underwent an FDA inspection from September 19-26, 2018. This initial inspection, conducted under the Quality System Inspection Technique (QSIT) for medical device manufacturers, focused on the firm's Corrective and Preventive Actions (CAPA) and Production and Process Controls for porous plasma spray and hydroxyapatite (HA) coatings. The inspection resulted in a six-item FDA Form 483, detailing significant observations of non-compliance with the Quality System Regulation (21 CFR Part 820). Key issues included inadequate monitoring of a validated process (21 CFR 820.75(b)), insufficient validation of a process that cannot be fully verified by subsequent inspection and test (21 CFR 820.75(a)), and improperly established procedures for managing customer complaints (21 CFR 820.198(a)), as "customer feedback" providing information on non-conforming devices was not routinely documented or evaluated as complaints. Additional observations noted deficiencies in calibration procedures, sampling justification, and statistical rationale. Management acknowledged the observations and "Promised to correct" the issues. The company committed to revalidating affected processes and providing a detailed timeline for corrective actions in their official written response to the FDA.