483
American Welding & Gas Inc.American Welding & Gas Inc. – FDA 483, Jul 11, 2019
Record Details
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procedures were properly drafted, reviewed, and approved by its Quality Control Unit, instead relying on external or outdated procedures.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.
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ID · f0a281b0-de1d-4878-b7fb-0c829bc7aec1
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