# FDA 483 - Olaregen Therapeutix Inc. - April 03, 2020

Source: https://www.keypedia.com/records/483/olaregen-therapeutix-inc/3e395610-984e-4505-953d-467bec0f1e2f

> FDA 483 for Olaregen Therapeutix Inc. on April 03, 2020. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Olaregen Therapeutix Inc.
- Inspection Date: 2020-04-03
- Product Type: device
- Office Name: Division of Human and Animal Food Operations - East I
- Summary: Olaregen Therapeutix Inc., a medical device manufacturer in New Hyde Park, NY, was issued a Form FDA 483 following an inspection. The inspection revealed a significant compliance issue related to the firm's failure to maintain written Medical Device Reporting (MDR) procedures. Specifically, the firm lacked electronic MDR procedures for submitting reports on serious injuries and death incidents.

## Related Officers

- [investigator](https://www.keypedia.com/people/kwong-p-lee/f4778925-1fad-4988-9e39-86482896c4fa)

Company: https://www.keypedia.com/companies/olaregen-therapeutix-inc/0acec554-e12e-4798-97fb-247d8d45a594

Office: https://www.keypedia.com/offices/division-of-human-and-animal-food-operations-east-i/a807f00e-d780-40b8-b233-1eb92ece8961