# FDA 483 - Menicon America, Inc. - December 19, 2024

Source: https://www.keypedia.com/records/483/menicon-america-inc/0f7f6fbb-f96c-42ac-bb40-5dbdc439a4be

> FDA 483 for Menicon America, Inc. on December 19, 2024. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Menicon America, Inc.
- Inspection Date: 2024-12-19
- Product Type: device
- Office Name: New England District Office
- Summary: During an FDA inspection from December 17-19, 2024, Menicon America, Inc. in North Billerica, MA, was cited for inadequate corrective and preventive action (CAPA) procedures. The firm's CAPA system failed to ensure that corrective actions were verified for effectiveness and did not properly document extensions for overdue CAPAs. This indicates a significant deficiency in their quality system for manufacturing.

## Related Officers

- [investigator](https://www.keypedia.com/people/james-p-finn/70e5c36c-2711-449b-bf73-e08b4dd58449)

Company: https://www.keypedia.com/companies/menicon-america-inc/20fee8ca-c3a2-41e6-8111-914a6b97e48e

Office: https://www.keypedia.com/offices/new-england-district-office/aa458072-2f1d-4231-89f5-21ba7a3b7144