# FDA 483 - Aurolab Trust - February 06, 2020

Source: https://www.keypedia.com/records/483/aurolab-trust/3f454d53-aa7b-418c-a584-15e673b1544a

> FDA 483 for Aurolab Trust on February 06, 2020. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Aurolab Trust
- Inspection Date: 2020-02-06
- Product Type: device
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: An FDA inspection of Aurolab in Madurai, India, from February 3-6, 2020, identified a significant deficiency in the firm's complaint handling procedures. Specifically, the company failed to adequately establish procedures for receiving, reviewing, and evaluating complaints, including proper documentation and justification for events deemed non-reportable under Medical Device Reporting (MDR) regulations. This indicates a moderate severity issue related to quality system compliance and patient safety reporting.

## Related Officers

- [Consultant](https://www.keypedia.com/people/seema-singh/7f3f7209-1749-46ee-8829-f305c5512e38)

Company: https://www.keypedia.com/companies/aurolab-trust/f1a20d31-3e35-4aac-bdbe-b2d3a2edf310

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