# FDA 483 - Johnson & Johnson Vision Care Ireland UC - February 15, 2022

Source: https://www.keypedia.com/records/483/johnson-johnson-vision-care-ireland-uc/c3cbfcf5-1ee2-45d6-9102-d2c03f0b7eff

> FDA 483 for Johnson & Johnson Vision Care Ireland UC on February 15, 2022. Product: other. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Johnson & Johnson Vision Care Ireland UC
- Inspection Date: 2022-02-15
- Product Type: other
- Office Name: Office of Biological Products Operations - Division I
- Summary: An FDA inspection of Johnson & Johnson Vision Care Ireland US in Limerick, Ireland, a combination drug/device manufacturer, identified 12 significant deficiencies. These issues span inadequate manufacturing process controls, critical data integrity failures in laboratory and electronic records, and a lack of robust quality unit oversight. The firm also demonstrated weaknesses in its CAPA processes, supplier management, and employee GMP training, indicating systemic non-compliance with cGMP requirements.

## Related Officers

- [Compliance Officer](https://www.keypedia.com/people/yasamin-ameri/73021772-c960-4c65-aa30-cb490866ee58)

Company: https://www.keypedia.com/companies/johnson-johnson-vision-care-ireland-uc/1c30ff5b-9a45-455e-8a6f-632d82c750ca

Office: https://www.keypedia.com/offices/office-of-biological-products-operations-division-i/49c53dac-7724-4c8c-8708-4f5779ea69c1