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483
•Arrow Medical Limited•October 31, 2019

FDA 483 - Arrow Medical Limited - October 31, 2019

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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.

Company
Arrow Medical Limited
Inspection Date
October 31, 2019
Product Type
Device
Office
Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
Person
  • Ronald Ifraimov (investigator)
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ID · b3975002-9239-4607-b018-eb8164614e01

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