483
The Tender CorporationFDA 483 - The Tender Corporation - October 26, 2018
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Record Details
The FDA inspected Tender Corporation, a manufacturer, and issued a Form 483 citing two observations. The firm failed to establish procedures for corrective and preventive actions, specifically regarding the analysis of deviations and complaints. Additionally, complaint files were not adequately maintained, lacking proper documentation for uninvestigated complaints or thorough review of potential device or package failures.
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ID · c0c972dc-534f-4cba-a647-160b207c99c0