# FDA 483 - Beaver Visitec International, Inc. - September 18, 2024

Source: https://www.keypedia.com/records/483/beaver-visitec-international-inc/1758406e-ad08-49ea-9412-fcfa1be426ee

> FDA 483 for Beaver Visitec International, Inc. on September 18, 2024. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Beaver Visitec International, Inc.
- Inspection Date: 2024-09-18
- Product Type: device
- Office Name: New England District Office
- Summary: An FDA inspection of Beaver Visitec International, Inc. in Waltham, MA, revealed a significant issue with medical device reporting. The firm failed to submit numerous Medical Device Reports (MDRs) within the required 30-day timeframe. These late reports were associated with adverse events involving ophthalmic surgical knives where the safety shield was not fully engaged in the packaging.

## Related Officers

- [Nabil Nakhoul](https://www.keypedia.com/people/nabil-nakhoul/d676e9c9-566c-4e59-84e8-1dc474e4e48d)

Company: https://www.keypedia.com/companies/beaver-visitec-international-inc/3b2b81f4-f421-40ee-ade1-13dc04e3fcea

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