COOPERVISION MANUFACTURING LTDJanuary 10, 2019

FDA 483 - COOPERVISION MANUFACTURING LTD - January 10, 2019

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Record Details

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.

Company: COOPERVISION MANUFACTURING LTD
Inspection Date: January 10, 2019
Product Type: Device
Office: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
Person: Seema Singh (Consultant)

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ID · 90d2aa0f-37c3-4a7d-af01-efea7058d637