# FDA 483 - Scientific Supplies & Technology, Inc. - November 09, 2023

Source: https://www.keypedia.com/records/483/scientific-supplies-technology-inc/588ee19b-5063-47e9-ba8f-ca53b2c7c0e2

> FDA 483 for Scientific Supplies & Technology, Inc. on November 09, 2023. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Scientific Supplies & Technology, Inc.
- Inspection Date: 2023-11-09
- Product Type: device
- Office Name: Office of Medical Device and Radiological Health Division II
- Summary: Scientific Supplies & Technology, Inc. in Miami, FL, a manufacturer of clinical chemical reagents, was inspected and cited for significant deficiencies in its quality system. The inspection revealed a lack of established procedures for complaint handling, corrective and preventive actions, and Medical Device Reporting. Additionally, the firm failed to maintain device history records for its Class 2 devices.

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Company: https://www.keypedia.com/companies/scientific-supplies-technology-inc/5c4808c3-4e04-430a-9b36-fa67ed283625

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