483
McNeil Healthcare, LLCFDA 483 - McNeil Healthcare, LLC - October 24, 2019
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An FDA inspection of McNeil Healthcare, Inc. in West Haven, CT, a surgical drape contract manufacturer/repacker, revealed inadequate procedures for equipment calibration and maintenance. Specifically, the firm failed to ensure equipment was calibrated to traceable standards, document calibration instruments, and verify the weight blocks used for calibration.
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ID · e89ea588-cd89-43f2-9434-afa7ff142559