483
Arrow Medical LimitedArrow Medical Limited – FDA 483, Oct 31, 2019
Record Details
An FDA inspection of Arrow Medical Limited, a contract manufacturer in Kington, Herefordshire, from October 28-31, 2019, revealed significant deficiencies. Observations included inadequate procedures for complaint handling and medical device reporting, insufficient documentation for validated processes, and failures in corrective and preventive action effectiveness reviews. Additionally, device history records were not adequately maintained.
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ID · b3975002-9239-4607-b018-eb8164614e01
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