# FDA 483 - Howmedica Osteonics Corp. - December 01, 2023

Source: https://www.keypedia.com/records/483/howmedica-osteonics-corp/4382d6ee-490f-4f70-bb51-5cdae1d47922

> FDA 483 for Howmedica Osteonics Corp. on December 01, 2023. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Howmedica Osteonics Corp.
- Inspection Date: 2023-12-01
- Product Type: device
- Office Name: New Jersey District Office
- Summary: Howmedica Osteonics Corp. in Mahwah, NJ, was inspected by the FDA from November 15 to December 1, 2023. The inspection revealed deficiencies in the firm's training procedures, specifically noting that required training for sales representatives was not adequately established or completed. This indicates a lapse in the firm's quality system regarding personnel training.

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Company: https://www.keypedia.com/companies/howmedica-osteonics-corp/6d54b7ca-0e29-4587-878e-94afc700f54c

Office: https://www.keypedia.com/offices/new-jersey-district-office/6ff5e2e9-5cff-44c7-af24-5a55329a8248