# FDA 483 - Precipart Corp - February 09, 2018

Source: https://www.keypedia.com/records/483/precipart-corp/68d03603-b09b-40ba-86ac-b4479a930d83

> FDA 483 for Precipart Corp on February 09, 2018. Product: device. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Precipart Corp
- Inspection Date: 2018-02-09
- Product Type: device
- Office Name: Division of Human and Animal Food Operations - East I
- Summary: PRECIPART CORPORATION, a contract manufacturer in Farmingdale, NY, was cited for failing to develop written Medical Device Reporting (MDR) procedures. The firm also lacked agreements with its sole medical device customer to define responsibility for MDR reportable events. This indicates a significant gap in their quality system regarding adverse event reporting.

## Related Documents

- [483 - 2021-02-25](https://www.keypedia.com/records/483/precipart-corp/4f0071a0-ad24-4a8a-8e8f-3f90806a849e)

## Related Officers

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

Company: https://www.keypedia.com/companies/precipart-corp/23370f3c-d19d-4cd2-9369-c9c780b57c5a

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