# FDA 483 - Otodynamics Limited - July 27, 2022

Source: https://www.globalkeysolutions.net/records/483/otodynamics-limited/78579206-4c15-4528-a6aa-4a034394e481

> FDA 483 for Otodynamics Limited on July 27, 2022. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Otodynamics Limited
- Inspection Date: 2022-07-27
- Product Type: device
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: Otodynamics Limited, a manufacturer in Hatfield, Hertfordshire, was inspected by the FDA from July 25-27, 2022. The inspection revealed that the firm's procedures for receiving, reviewing, and evaluating complaints were not adequately established. Specifically, complaints were not consistently processed in a timely manner, with several files exhibiting extended open periods.

## Related Officers

- [Shannon A. Gregory](https://www.globalkeysolutions.net/people/shannon-a-gregory/3e791321-dced-4e1d-89a1-3da91d577961)

Company: https://www.globalkeysolutions.net/companies/otodynamics-limited/7928e076-b9e2-4069-be0e-b127e9aa7dd5

Office: https://www.globalkeysolutions.net/offices/division-of-clinical-evidence-and-analysis-1-clinical-policy-and-quality/5f95da17-30bb-423f-b892-5ea041823fbd