Audit Procedures, Other Problems Flagged at Isolux Facility
Isolux received a Form 483 for not adequately establishing procedures for quality audits, for not implementing a supplier evaluation procedure, and other observations.
In a September 2016 inspection of the firm’s Naples, Fla., facility, the FDA observed that Isolux’s internal audit procedures did not ensure all applicable quality system requirements were reviewed.
In addition, quality audits were conducted by individuals with no direct responsibility for the matters being audited, corrective actions were not taken when necessary, and audit reports were not reviewed by management having responsibility for the matters audited.
Moreover, the company had not conducted any internal audits. The FDA noted this was a repeat observation from another Form 483 issued in January 2010.
The FDA also said Isolux did not implement one of its supplier evaluation procedures. Specifically, it failed to document the evaluation of most of its current suppliers and contractors on file, and there was no documentation that its suppliers and contractors had agreed to notify the company of changes in products or services.
The Form 483 also noted that the firm had not developed adequate written reporting procedures. For example, the existing procedures did not include definitions of medical device reportable events, electronic reporting requirements and instructions, or a reporting time frame of five business days when requested in writing by the FDA.
Inspectors also faulted the company’s design change procedures for not including validation or verification requirements, its complaint handling procedures for improper documentation, its servicing procedures for not requiring that serviced devices conformed to specifications, and its inadequate training procedures.
A spokesperson for Isolux declined to comment.
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