483
Strata Skin Sciences, Inc.FDA 483 - Strata Skin Sciences, Inc. - August 22, 2024
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Strata Skin Sciences, Inc. in Carlsbad, CA, a medical device manufacturer, received one FDA Form 483 observation following an inspection. The observation cited inadequate documentation and approval of process validation activities for their XTRAC Laser System AL10000. This indicates a deficiency in their quality system regarding manufacturing process controls.
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ID · aa9a1cab-6f6b-4875-9d02-92c5974e1868