483
Elite Medical Supply of New York, LLCElite Medical Supply of New York, LLC – FDA 483, Feb 11, 2020
Record Details
An FDA inspection of Elite Medical Supply of New York, LLC, a medical device specification developer in West Seneca, NY, identified a significant quality control issue. The firm's procedures for accepting incoming product were found to be inadequate. Specifically, the inspection revealed that the company's incoming inspection work instructions allowed for re-sampling and acceptance of a lot even if the initial sample failed to meet specified requirements.
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ID · 56a5549e-95fc-4cec-971a-43bf882bd6c3
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