# FDA 483 - Helget Gas Products Inc - May 25, 2023

Source: https://www.keypedia.com/records/483/helget-gas-products-inc/5812e7cd-de0d-4de2-998a-1a9cb04d4813

> FDA 483 for Helget Gas Products Inc on May 25, 2023. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Helget Gas Products Inc
- Inspection Date: 2023-05-25
- Product Type: drugs
- Office Name: Division of Human and Animal Food Operations - West II
- Summary: Helget Gas Products Inc. in Bridgeton, MO, a medical gas manufacturer, was inspected and received a Form 483 with eight observations. The inspection revealed significant deficiencies in quality control, labeling procedures, complaint handling, product testing, employee training, annual reviews, and facility maintenance. Key issues include illegible lot codes, lack of SOPs for label control, and failure to conduct required product testing.

## Related Officers

- [Investigator](https://www.keypedia.com/people/michele-perry-williams/80741e95-8df3-41c9-b9b8-499fcb97921d)

Company: https://www.keypedia.com/companies/helget-gas-products-inc/5263ef73-affb-4767-8acc-baf2c95828ab

Office: https://www.keypedia.com/offices/division-of-human-and-animal-food-operations-west-ii/8851d151-0390-4d17-be66-fd86d12aa6b8