483
LaunchPOrt LlcLaunchPOrt Llc – FDA 483, Jul 24, 2019
Record Details
An FDA inspection of Engineered Medical Systems Baltimore, a medical device contract manufacturer, revealed two significant observations. The firm failed to validate a manufacturing process whose results cannot be fully verified by subsequent inspection and test. Additionally, software used as part of production and the quality system had not been validated for its intended use.
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ID · a6e36b69-e29a-4bd4-965f-d8a31aac3e89
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