# FDA 483 - Arrow Medical Limited - October 31, 2019

Source: https://www.globalkeysolutions.net/records/483/arrow-medical-limited/b3975002-9239-4607-b018-eb8164614e01

> FDA 483 for Arrow Medical Limited on October 31, 2019. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Arrow Medical Limited
- Inspection Date: 2019-10-31
- Product Type: device
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: 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.

## Related Officers

- [investigator](https://www.globalkeysolutions.net/people/ronald-ifraimov/b4ce8b79-3fa2-4862-b7a4-68e14e45d87a)

Company: https://www.globalkeysolutions.net/companies/arrow-medical-limited/d556c50e-9d93-4000-9a94-3c9b7103652e

Office: https://www.globalkeysolutions.net/offices/division-of-clinical-evidence-and-analysis-1-clinical-policy-and-quality/5f95da17-30bb-423f-b892-5ea041823fbd