483
LaunchWorks LLCLaunchWorks LLC – FDA 483, Oct 23, 2019
Record Details
An FDA inspection of Launchworks Manufacturing Lab in Beverly, MA, a manufacturer of newborn screening test systems, identified one significant observation. The firm failed to establish procedures for controlling environmental conditions in its clean room, which was also not certified annually as required. This indicates a lapse in quality system requirements related to environmental control.
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ID · 7efd0e36-6a5b-40c2-9140-2c8027d45aa6
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