FDANews
The QMN Weekly Bulletin

Design Control, CAPA Issues Lead to Warning Letter for Nuga

Aug. 7, 2015

South Korean devicemaker Nuga Medical received an FDA warning letter related to a host of GMP woes, including design control and CAPA procedures.

The Gwangju City company makes therapeutic heating and massage devices.

The Dec. 24 letter says Nuga’s design control procedure is inadequate because it doesn’t require the company to document investigations into device failures that occurred during design validation. As of the Aug. 25 to 28, 2014, inspection, Nuga hadn’t identified design validation failures dating to January 2012.

NUGA’s corrective and preventive action policies were also found wanting, with no corrective actions initiated for six of the seven quality issues identified as needing investigation. Further, the company’s complaint handling procedures don’t include requirements to ensure that complaints are evaluated for reporting to the FDA. None of the 73 complaints Nuga received about heating belts that melted or sparked at the connector were investigated, the FDA says. And the company lacks written procedures for adverse event reporting.

The FDA also dinged Nuga’s practices around design changes. For example, the devicemaker failed to document a change in the type of fuse needed for design validation and distributed at least five devices with a redesigned connector without establishing a validation protocol for the change.

The investigator also noted that some checklists for certifying that devices are ready for sale had been marked in advance with how many devices would be rejected after review, and some of Nuga’s manufacturing equipment was never qualified per the company’s written procedures.

For decades, CAPA has been the number one item cited by the FDA in 483s, and it’s the first thing FDA inspectors look at. But many firms don’t understand some of the most important issues underlying a good CAPA program. Gain this understanding with FDAnews’ CAPA: Noun or Verb? - Webinar CD/Transcript. Think CAPA is a noun? Think again. A strong CAPA program is about containment. It’s about taking action. CAPA is a verb.