FDA 483 - Anesthetic Gas Reclamation Inc. - May 04, 2023

Anesthetic Gas Reclamation Inc. in Dallas, TX, was cited with six observations during an FDA inspection regarding its manufacturing of Class 2 Dynamic Gas Scavenging System-2 (DGSS-2) devices. The inspection revealed significant deficiencies across multiple quality system areas, including finished device acceptance, supplier evaluation, equipment calibration, complaint handling, internal audits, and document control. These issues indicate a lack of adequate procedures and adherence to established quality management practices.