483
Micro Typing Systems, Inc.FDA 483 - Micro Typing Systems, Inc. - December 10, 2019
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Record Details
An FDA inspection of Micro Typing Systems, Inc. in Pompano Beach, FL, an IVD manufacturer, revealed significant deficiencies across four observations. The firm failed to adequately establish corrective and preventive action procedures, maintain proper change control records, control non-conforming products with defined timelines, and ensure document control for electronic data protection.
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ID · 99d08611-b843-48fb-b2a9-d8beddb8b4fa