# FDA 483 - Thrombolex Inc - March 30, 2023

Source: https://www.keypedia.com/records/483/thrombolex-inc/4d69896a-f2a9-41c3-bb33-d43d7e1df39c

> FDA 483 for Thrombolex Inc on March 30, 2023. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Thrombolex Inc
- Inspection Date: 2023-03-30
- Product Type: device
- Office Name: Philadelphia District Office
- Summary: Thrombolex Inc, a medical device manufacturer in New Britain, PA, was inspected by the FDA from March 29-30, 2023. The inspection revealed one significant observation regarding the firm's failure to submit a Medical Device Report (MDR) for a device malfunction. This malfunction, involving a broken guidewire port on their BASHIR Endovascular Catheter Plus, was likely to cause or contribute to a serious injury if it were to recur.

## Related Officers

- [Investigator at US Food and Drug Administration](https://www.keypedia.com/people/brian-s-keefer/4fec578b-ca72-4d79-8634-3a9fe7ecd9a5)

Company: https://www.keypedia.com/companies/thrombolex-inc/51351603-818c-4f4e-88d7-635937ee1a9d

Office: https://www.keypedia.com/offices/philadelphia-district-office/c5ec7398-b3d5-4125-9793-fb7b972578d8