# FDA 483 - XL PRECISION TECHNOLOGIES LTD - August 29, 2025

Source: https://www.keypedia.com/records/483/xl-precision-technologies-ltd/a235fd6b-db31-40a1-8b12-543746a2ba52

> FDA 483 for XL PRECISION TECHNOLOGIES LTD on August 29, 2025. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: XL PRECISION TECHNOLOGIES LTD
- Inspection Date: 2025-08-29
- Product Type: device
- Office Name: Office of Inspections and Investigations
- Summary: XL PRECISION TECHNOLOGIES LTD, a medical device manufacturer in Stockton-On-Tees, United Kingdom, was cited for significant deficiencies in its quality system. The FDA inspection revealed inadequate establishment and implementation of corrective and preventive action procedures, as well as insufficient validation of a critical passivation process. Additionally, the firm failed to adequately establish procedures for monitoring and controlling process parameters for this validated process.

## Related Officers

- [Joshua J. Silvestri](https://www.keypedia.com/people/joshua-j-silvestri/433e29b3-ce5f-44d2-9984-7a6cb61e1824)

Company: https://www.keypedia.com/companies/xl-precision-technologies-ltd/1ed6acdd-3096-44d9-b196-d422f06f141c

Office: https://www.keypedia.com/offices/office-of-inspections-and-investigations/7dd0b904-a3df-46bc-a7b2-70ddb6f809c8