# FDA 483 - Remidio Innovative Solutions Pvt. Ltd. - February 07, 2019

Source: https://www.globalkeysolutions.net/records/483/remidio-innovative-solutions-pvt-ltd/96f33ff8-e264-4d19-a860-f959e06b6cf5

> FDA 483 for Remidio Innovative Solutions Pvt. Ltd. on February 07, 2019. Product: device. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Remidio Innovative Solutions Pvt. Ltd.
- Inspection Date: 2019-02-07
- Product Type: device
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: An FDA inspection of Remidio Innovative Solutions Pvt. Ltd. in Bangalore, India, identified an inadequacy in their design change procedures. The firm failed to establish adequate procedures for evaluating changes to their ophthalmic camera to determine if premarket submissions (510(k) or PMA) were required. Additionally, the procedures did not mandate documenting a rationale when verification or validation activities were not performed.

## Related Officers

- [Shaquenta Perkins](https://www.globalkeysolutions.net/people/shaquenta-perkins/00369bbd-5784-42c2-847e-202c8b1b87a2)

Company: https://www.globalkeysolutions.net/companies/remidio-innovative-solutions-pvt-ltd/5baf80b0-3761-4553-92e6-46139e1d1965

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