# FDA 483 - Precipart Corp - February 25, 2021

Source: https://www.keypedia.com/records/483/precipart-corp/4f0071a0-ad24-4a8a-8e8f-3f90806a849e

> FDA 483 for Precipart Corp on February 25, 2021. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Precipart Corp
- Inspection Date: 2021-02-25
- Product Type: device
- Office Name: Division of Human and Animal Food Operations - East I
- Summary: PRECIPART CORPORATION, a medical device manufacturer in Farmingdale, NY, was inspected by the FDA from February 23-25, 2021. The inspection resulted in one observation. The firm failed to maintain written Medical Device Reporting (MDR) procedures, specifically lacking an approval signature and effective date.

## Related Documents

- [483 - 2018-02-09](https://www.keypedia.com/records/483/precipart-corp/68d03603-b09b-40ba-86ac-b4479a930d83)

## Related Officers

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

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