Advanced Instrumentations, Inc.March 10, 2023

FDA 483 - Advanced Instrumentations, Inc. - March 10, 2023

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An FDA inspection of Advanced Instruments, Inc. in Miami, FL, a repackager/relabeler, revealed significant deficiencies in their quality system. The firm failed to adequately implement procedures for corrective and preventive actions, customer complaint handling, and nonconforming product rework, with two of these issues being repeat observations. Additionally, equipment calibration documentation for warehouse humidity levels was found to be inadequate.

Company: Advanced Instrumentations, Inc.
Inspection Date: March 10, 2023
Product Type: Device
Office: Office of Medical Device and Radiological Health Division II
Person: Ebony D. Sanon

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ID · 38f571d3-40cb-4834-a679-07f7dc192321