FDAnews Device Daily Bulletin
Medical Devices / Inspections and Audits

Ecleris Scolded for Procedural Issues

Feb. 5, 2019
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EUSA Global, doing business as Ecleris USA, drew a Form 483 after an FDA inspection revealed problems with CAPA procedures and management reviews, among other issues.

During its Oct. 11-17, 2018 inspection of the firm’s Medley, Florida site, the agency found deficiencies with one of the two CAPA records available for investigation. The record involved engineering changes put in place by the corporate headquarters for a medical fiberoptic light source that were not announced to the facility.

While the root cause was identified as an inadequate process to transfer design changes from HQ to the facility, the plan didn’t sufficiently address the root cause. The record also lacked approval signatures needed for initiation and had no documentation of completed corrective actions or the status of unfinished ones.

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