# FDA 483 - CooperVision Lens Care Limited - November 15, 2018

Source: https://www.globalkeysolutions.net/records/483/coopervision-lens-care-limited/bdd92c5f-4cbd-4149-a9b9-76bde3321f71

> FDA 483 for CooperVision Lens Care Limited on November 15, 2018. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: CooperVision Lens Care Limited
- Inspection Date: 2018-11-15
- Product Type: device
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: CooperVision Lens Care Limited in Ashford, Kent, United Kingdom, was cited with five observations during an FDA inspection. The inspection revealed significant deficiencies in environmental controls, process validation for water sampling, implementation of validated test methods, corrective and preventive action procedures, and the statistical rationale for sampling methods. These issues indicate a lack of adequate control over critical manufacturing processes and quality systems.

## Related Documents

- [483 - 2018-11-12](https://www.globalkeysolutions.net/records/483/coopervision-lens-care-limited/06920370-ec8e-454c-a7c5-56944ba7a65f)

## Related Officers

- [investigator](https://www.globalkeysolutions.net/people/karen-m-rodriguez/fcef1f49-583d-45ab-80e2-4c34793fd722)

Company: https://www.globalkeysolutions.net/companies/coopervision-lens-care-limited/7a2bb4ea-3426-4890-98b2-68d262e501c9

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