The QMN Weekly Bulletin

FDA Sends Warning Letter to Fundus Photo Over Inadequate Records

May 5, 2017

The FDA slapped medical device company Fundus Photo with a Form 483, citing procedural and record-keeping failures.

In a December 2016 inspection of the medical device manufacturer’s Lenexa, Kans., facility, FDA inspectors uncovered numerous problems with records. For example, the facility did not keep adequate device history records, and failed to maintain formal complaint investigation records or master device records. The agency noted an issue with master records in a previous inspection.

The inspection also uncovered numerous procedural issues at the facility. For example, the facility failed to conduct internal quality systems audits and failed to established adequate procedures to ensure compliance with requirements for incoming components. The firm also lacked the required testing records for components such as adapters or cables.

Inspectors also found Fundus failed to establish comprehensive procedures for corrective and preventive actions.

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