# FDA 483 - Ansh Labs, LLC - February 10, 2020

Source: https://www.keypedia.com/records/483/ansh-labs-llc/51415e61-b923-441c-b7ea-dc80c346952f

> FDA 483 for Ansh Labs, LLC on February 10, 2020. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Ansh Labs, LLC
- Inspection Date: 2020-02-10
- Product Type: device
- Office Name: Dallas District Office
- Summary: An FDA inspection of Ansh Labs, LLC, a medical device manufacturer in Webster, TX, revealed a significant deficiency related to Medical Device Reporting (MDR). The firm failed to develop, maintain, and implement written procedures for handling and processing information on MDR events and maintaining MDR files. This indicates a lack of established processes for critical post-market surveillance activities.

## Related Officers

- [Ellen J. Tave](https://www.keypedia.com/people/ellen-j-tave/a70cd3ed-957f-471b-82ff-24ca7c65bc10)

Company: https://www.keypedia.com/companies/ansh-labs-llc/b796fba8-4604-45fe-aaa7-0b37d5d211d9

Office: https://www.keypedia.com/offices/dallas-district-office/2d1ee9ae-c44c-4494-8186-a920a69b98f9