483
Vacumed, Div of Vacumetrics IncVacumed, Div of Vacumetrics Inc – FDA 483, Feb 21, 2020
Record Details
An FDA inspection of Vacumed, Div of Vacumetrics Inc, a Class II medical device manufacturer in Ventura, CA, revealed two significant observations. The firm was cited for failing to adequately maintain records of changes to documents, specifically Device Master Records. Additionally, procedures for corrective and preventive actions were found to be incomplete and not consistently followed.
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ID · 1abff1e1-9cef-44a9-b11f-2c47ceea79a7
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