# FDA 483 - Natech Plastics Inc - October 06, 2022

Source: https://www.keypedia.com/records/483/natech-plastics-inc/1c6bc1d5-7d5e-448f-803c-bd8b32a7fea7

> FDA 483 for Natech Plastics Inc on October 06, 2022. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Natech Plastics Inc
- Inspection Date: 2022-10-06
- Product Type: device
- Office Name: Division of Human and Animal Food Operations - East I
- Summary: Natech Plastics Inc, a manufacturer in Ronkonkoma, NY, was inspected by the FDA from October 4-6, 2022. The inspection identified a significant procedural deficiency related to Medical Device Reporting (MDR). Specifically, the firm lacked established written MDR procedures detailing filing timeframes and required forms.

## Related Officers

- [investigator](https://www.keypedia.com/people/ronald-ifraimov/b4ce8b79-3fa2-4862-b7a4-68e14e45d87a)

Company: https://www.keypedia.com/companies/natech-plastics-inc/09b8830c-9350-407c-99bf-cae9d75ec2ca

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