# FDA 483 - COOPERVISION MANUFACTURING LTD - January 10, 2019

Source: https://www.keypedia.com/records/483/coopervision-manufacturing-ltd/90d2aa0f-37c3-4a7d-af01-efea7058d637

> FDA 483 for COOPERVISION MANUFACTURING LTD on January 10, 2019. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: COOPERVISION MANUFACTURING LTD
- Inspection Date: 2019-01-10
- Product Type: device
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: An FDA inspection of COOPERVISION MANUFACTURING LTD in Southampton identified a significant issue with the documentation of process validation activities. The firm failed to adequately detail testing procedures for scanners and vision systems used in the labeling and packaging of various contact lenses. This indicates a deficiency in ensuring consistent product quality and regulatory compliance.

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Company: https://www.keypedia.com/companies/coopervision-manufacturing-ltd/f3893456-6af6-4594-bf05-6165cd12a9c4

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