# FDA 483 - Frostime Llc - October 28, 2020

Source: https://www.globalkeysolutions.net/records/483/frostime-llc/7dbba5f3-e6fc-4550-b602-5e6637360c1e

> FDA 483 for Frostime Llc on October 28, 2020. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Frostime Llc
- Inspection Date: 2020-10-28
- Product Type: device
- Office Name: Division of Human and Animal Food Operations - East I
- Summary: During an inspection, the FDA cited Frostime Llc, a manufacturer in New York, NY, for failing to maintain adequate procedures. The firm lacked electronic Medical Device Reporting (eMDR) procedures necessary for handling death and serious injury incidents. This indicates a significant lapse in their regulatory compliance regarding adverse event reporting.

## Related Officers

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

Company: https://www.globalkeysolutions.net/companies/frostime-llc/ffa5ba8b-6d52-4a2b-98e0-8fb629e54272

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