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

Source: https://www.keypedia.com/records/483/advanced-instrumentations-inc/ad21f2a1-9919-426e-a608-17aeceb9588d

> FDA 483 for Advanced Instrumentations, Inc. on March 10, 2023. Product: devices. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Advanced Instrumentations, Inc.
- Inspection Date: 2023-03-10
- Product Type: devices
- Office Name: Food and Drug Administration
- Summary: During an inspection conducted from March 6 to March 10, 2023, the U.S. Food and Drug Administration (FDA) identified significant quality system deficiencies at Advanced Instrumentations, Inc., a medical device repackager/relabeler located in Miami, FL. The inspection resulted in a Form FDA-483 listing four key observations, two of which were repeat findings from a previous inspection in January 2020. The primary issues centered on the company's failure to adequately establish and implement its quality procedures. Specifically, the FDA noted deficiencies in the corrective and preventive action (CAPA) system, where numerous CAPAs were closed without verifying completion or effectiveness, and others lacked required implementation plans. Complaint handling procedures were also found to be inadequate, with several customer complaint files missing critical information such as receipt dates, medical device reportability decisions, investigation details, or resolutions. Further observations included a lack of adherence to procedures for managing nonconforming products, with records incomplete or closed prematurely. Additionally, the company failed to ensure proper documentation of equipment calibrations for warehouse humidity monitoring, which is essential for product storage conditions. Advanced Instrumentations, Inc. has indicated its commitment to correcting all observations, and is responsible for implementing robust corrective actions to ensure full compliance with regulatory quality system requirements.

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Company: https://www.keypedia.com/companies/advanced-instrumentations-inc/4d9b9f1e-df18-4b76-ba69-fbb66b575fc4

Office: https://www.keypedia.com/offices/food-and-drug-administration/437fdb2a-5048-42aa-aaea-ea28efe65516