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

Source: https://www.globalkeysolutions.net/records/483/advanced-instrumentations-inc/38f571d3-40cb-4834-a679-07f7dc192321

> FDA 483 for Advanced Instrumentations, Inc. on March 10, 2023. Product: device. 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: device
- Office Name: Office of Medical Device and Radiological Health Division II
- Summary: 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.

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## Related Officers

- [Ebony D. Sanon](https://www.globalkeysolutions.net/people/ebony-d-sanon/703dc125-1019-43d1-9598-1bdc92026e2b)

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

Office: https://www.globalkeysolutions.net/offices/office-of-medical-device-and-radiological-health-division-ii/ae9bd439-479a-420d-9dd8-9fe1fc0863d6