483
Pathen Medical LLCPathen Medical LLC – FDA 483, Nov 1, 2019
Record Details
Pathen Medical LLC, a medical device manufacturer in Sanford, FL, was inspected by the FDA. The inspection revealed deficiencies in the firm's purchasing controls, specifically regarding the evaluation and selection of third-party sterilization companies. Additionally, the validation effort for their (b)(4) Administration Sets lacked an appropriately designed Physical Performance Qualification.
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ID · adbf6673-59b4-4920-aa11-256b49c27049
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