Granite Microsystems, Inc. – FDA EIR, Nov 21, 2024

Granite Microsystems, Inc., a medical device contract manufacturer located in Mequon, WI, underwent an FDA inspection from November 18 to November 21, 2024. The inspection revealed significant compliance issues primarily related to the control and documentation of non-conforming products and the validation of inspection processes.

Key violations include inadequate procedures for managing non-conforming products. The firm's procedure, Control of Non-Conforming Product QP-030, lacks requirements for evaluating nonconformities to determine the necessity of an investigation. Additionally, the Nonconformity Forms were found to be inconsistently completed, often missing critical information such as investigation notes and rationale for corrective actions. For instance, several forms related to failed resistance testing lacked detailed investigation activities and rationale for decisions made.

Furthermore, the firm failed to validate a process whose results could not be fully verified by subsequent inspection and test. Specifically, there was no evidence to support the effectiveness of the visual inspection criteria used to identify defects, as outlined in their documented procedures.

Under the regulatory framework, Granite Microsystems is required to conduct internal audits to identify and rectify all violations of quality system requirements. The FDA expects the company to establish robust procedures for non-conforming products and validate inspection processes to ensure compliance. Immediate corrective actions should be implemented, and any objections or plans for corrective actions should be communicated to the FDA.