# FDA 483 - Veran Medical Technologies Inc - February 23, 2023

Source: https://www.globalkeysolutions.net/records/483/veran-medical-technologies-inc/ef65034c-ebec-4cad-9b6d-a94a899fd1b5

> FDA 483 for Veran Medical Technologies Inc on February 23, 2023. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Veran Medical Technologies Inc
- Inspection Date: 2023-02-23
- Product Type: device
- Office Name: Division of Human and Animal Food Operations - West II
- Summary: Veran Medical Technologies Inc. in Saint Louis, MO, was cited for significant deficiencies in its quality system during an FDA inspection. The firm failed to adequately report medical device adverse events, establish proper corrective and preventive actions, and thoroughly investigate device complaints. Additionally, a critical sterilization process was not revalidated after a manufacturing relocation, impacting thousands of distributed devices.

## Related Documents

- [483 - 2021-07-29](https://www.globalkeysolutions.net/records/483/veran-medical-technologies-inc/e3e02ce4-d948-463f-94e1-1d30da8a3313)

## Related Officers

- [Edward E. Lockwood](https://www.globalkeysolutions.net/people/edward-e-lockwood/3260b39e-9211-489f-8247-0ec3353e57ca)
- [issuing_officer](https://www.globalkeysolutions.net/people/mary-l-schuckmann/fdbfffff-ef4b-49a2-8ea3-6254a600aaac)

Company: https://www.globalkeysolutions.net/companies/veran-medical-technologies-inc/724017f0-cde6-424c-ab38-2be98f7d1700

Office: https://www.globalkeysolutions.net/offices/division-of-human-and-animal-food-operations-west-ii/8851d151-0390-4d17-be66-fd86d12aa6b8