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

Source: https://www.keypedia.com/records/483/anesthetic-gas-reclamation-inc/f863c3f8-362b-4d77-90d3-99a275c50f66

> FDA 483 for Anesthetic Gas Reclamation Inc. on May 04, 2023. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Anesthetic Gas Reclamation Inc.
- Inspection Date: 2023-05-04
- Product Type: device
- Office Name: Division of Human and Animal Food Operations - West III
- Summary: 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.

## Related Documents

- [483 - Unknown Date](https://www.keypedia.com/records/483/anesthetic-gas-reclamation-inc/5af789ab-e11c-4368-ba88-76bc34a4cc05)

## Related Officers

- [Terri E. Gibson](https://www.keypedia.com/people/terri-e-gibson/f1a80f95-a5c4-4cae-9a4b-e23f367770bb)

Company: https://www.keypedia.com/companies/anesthetic-gas-reclamation-inc/e3eea8ec-b6d1-4355-b094-441caf3e12ab

Office: https://www.keypedia.com/offices/division-of-human-and-animal-food-operations-west-iii/2cda09a5-06c4-433f-9df0-0d7903a6efab