Iowa Firm Hit for Inadequate Device History Records and Other Problems

The FDA wrote up a Tiffin, Iowa devicemaker for violations at its facility that included incomplete device history records, among other issues.

The agency’s inspection found Titronics Research & Development facility did not include all product labels, labeling or acceptance records, including the equipment used to conduct the acceptance activities in its device history records.

Titronics also failed to properly implement a nonconforming product procedure. The facility failed to use its nonconforming product form for any products, including discarded components and products returned for rework.