FDA 483 - EOSolutions Corp - December 07, 2023
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EOSolutions Corp in Miramar, FL, a specification developer of percutaneous catheter devices, was cited for two significant quality system deficiencies during an FDA inspection. The firm failed to adequately establish procedures for quality audits, including issues with a third-party auditor and delayed audit reports. Additionally, the company's training procedures were found to be inadequate, specifically regarding a sales and marketing employee who handled complaints without proper training.
ID · 19c789f8-d2b9-46a1-965a-6aacb6e9e5cb