FDA EIR - ErgoMed, Inc. - February 21, 2013

An FDA establishment inspection of Ergomed, Inc., a medical device specification developer located in San Antonio, TX, took place from February 19 to February 21, 2013. Conducted by the Texas Department of State Health Services under a federal contract, this was a preannounced Level I Quality System Inspection Technique (QSIT) inspection, adhering to the regulatory framework for medical device manufacturers. Ergomed, Inc. specializes in Class I medical devices, such as head restraints and tracheal tubes, performing various operations including inspection, quality control, repackaging, and distribution. While these devices are 510(k) exempt, they are not GMP exempt.

The inspection focused on management controls, corrective and preventive actions (CAPAs), and finished product inventory storage. Significantly, no major violations or issues were found. The inspection report confirms that no FDA Form 483 or DSHS E-14 was issued to the company's management. Minor administrative and clerical oversights were verbally noted, but these observations did not affect any of Ergomed, Inc.'s systems, processes, or products. As a result, the inspection concluded with a "No Action Indicated" (NAI) decision, indicating compliance with applicable regulations at the time of the inspection.