483
Scientific Supplies & Technology, Inc.FDA 483 - Scientific Supplies & Technology, Inc. - November 09, 2023
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Record Details
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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ID · 588ee19b-5063-47e9-ba8f-ca53b2c7c0e2