# FDA 483 - American Welding & Gas Inc. - July 11, 2019

Source: https://www.keypedia.com/records/483/american-welding-gas-inc/f0a281b0-de1d-4878-b7fb-0c829bc7aec1

> FDA 483 for American Welding & Gas Inc. on July 11, 2019. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: American Welding & Gas Inc.
- Inspection Date: 2019-07-11
- Product Type: drugs
- Office Name: Atlanta District Office
- Summary: An FDA inspection of American Welding & Gas. Inc., a medical gas manufacturer in Columbia, SC, revealed a significant deficiency in their quality system. The firm failed to ensure that written procedures were properly drafted, reviewed, and approved by its Quality Control Unit, instead relying on external or outdated procedures. This indicates a moderate severity issue regarding control over critical manufacturing processes.

## Related Officers

- [investigator](https://www.keypedia.com/people/lillie-d-witcher/6e879b86-97a9-48a2-aac6-9f13443b0d17)

Company: https://www.keypedia.com/companies/american-welding-gas-inc/d9202d49-a808-4a32-9b97-c09eff284fcf

Office: https://www.keypedia.com/offices/atlanta-district-office/7586d99a-288e-49d1-8c3d-d88b7354b7a7