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Medical Devices / Regulatory Affairs

FDA Hits Houston Devicemaker With Lengthy Warning Letter

Aug. 26, 2019

Houston-based medical devicemaker Talon received a lengthy FDA warning letter for design process and quality control issues following an inspection of the firm’s manufacturing facility.

Investigators found the firm’s corrective and preventive action procedures to be insufficient, noting that reports “failed to provide documented evidence that corrective actions taken were verified and/or implemented.” The letter noted several instances of CAPAs being closed before the underlying issues were resolved.

The warning letter also outlined failures to properly train staff, to routinely perform quality audits, and to keep proper quality control records. The agency highlighted that the firm’s response to the Form 483 inspection observations indicated quality audits were being performed, but “with poorly defined requirements.”

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