# FDA 483 - FLYMEDICAL SOLUTIONS LIMITED - February 13, 2019

Source: https://www.keypedia.com/records/483/flymedical-solutions-limited/d3816297-e6fa-446a-9de1-21ab2c9b542b

> FDA 483 for FLYMEDICAL SOLUTIONS LIMITED on February 13, 2019. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: FLYMEDICAL SOLUTIONS LIMITED
- Inspection Date: 2019-02-13
- Product Type: device
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: An FDA inspection of FLYMEDICAL SOLUTIONS LIMITED, a medical device establishment in Livingston, United Kingdom, identified one observation. The firm's purchasing control and supplier evaluation procedures were found to be inadequate. Specifically, they lacked requirements for obtaining evidence of control, such as process validation, from critical suppliers for critical operations.

## Related Officers

- [Principal ](https://www.keypedia.com/people/richard-k-vogel/3ddd8bff-24fd-40ee-b0a7-fb5333a520f5)

Company: https://www.keypedia.com/companies/flymedical-solutions-limited/a51c8abd-4c63-48e7-9642-3371d768080f

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