483
Aesculap Implant Systems LLCFDA 483 - Aesculap Implant Systems LLC - June 08, 2021
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Record Details
Aezculap Implant Systems LLC in Breinigsville, PA, was inspected by the FDA from June 7-8, 2021, resulting in one observation. The inspection found that the firm failed to document evaluations of out-of-calibration equipment and remedial actions. This indicates a lapse in quality system documentation for critical manufacturing equipment.
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ID · 6e7a4592-9d99-4a72-9ae5-fe62e537feff