# FDA 483 - Pan Medical Ltd. - April 07, 2016

Source: https://www.globalkeysolutions.net/records/483/pan-medical-ltd/a3b2ca18-5c4a-43bc-a931-31198937f4c1

> FDA 483 for Pan Medical Ltd. on April 07, 2016. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Pan Medical Ltd.
- Inspection Date: 2016-04-07
- Product Type: device
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: Pan Medical Ltd., a medical device manufacturer in Gloucester, United Kingdom, was cited for significant deficiencies in its quality system. Observations included inadequate process validation for a laser welder, insufficient design validation for a kyphoplasty catheter, incomplete risk analysis, and a lack of procedures and records for equipment maintenance. These issues indicate a systemic failure to ensure product quality and safety.

## Related Documents

- [483 - 2016-04-04](https://www.globalkeysolutions.net/records/483/pan-medical-ltd/bbca9634-b678-4dd7-a692-cb4d368cd593)

## Related Officers

- [Investigator](https://www.globalkeysolutions.net/people/janet-pulver/d46b01cd-8c3d-4a54-bb91-843e0f94de89)

Company: https://www.globalkeysolutions.net/companies/pan-medical-ltd/0eb36fc3-a065-4a17-aea7-edb4cf56910e

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