# FDA 483 - Kem Medical Products Corp - January 15, 2020

Source: https://www.globalkeysolutions.net/records/483/kem-medical-products-corp/d29db142-9f8a-4e62-8980-30c4628a49bc

> FDA 483 for Kem Medical Products Corp on January 15, 2020. Product: device. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Kem Medical Products Corp
- Inspection Date: 2020-01-15
- Product Type: device
- Office Name: Division of Human and Animal Food Operations - East I
- Summary: Kem Medical Products Corp, a medical device manufacturer in Farmingdale, NY, was cited for two observations during an FDA inspection. The firm failed to maintain written Medical Device Reporting (MDR) procedures, specifically lacking electronic MDR procedures for serious injuries and deaths. Additionally, complaint files were not adequately maintained, as the firm did not use its designated form to document consumer complaints since 2016.

## Related Documents

- [483 - 2022-07-21](https://www.globalkeysolutions.net/records/483/kem-medical-products-corp/75775f7f-d4f9-47e5-b237-c4af74083468)

## Related Officers

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

Company: https://www.globalkeysolutions.net/companies/kem-medical-products-corp/839eba3c-ce65-4e39-a7a5-7258eddea42a

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