# FDA 483 - Kem Medical Products Corp - July 21, 2022

Source: https://www.globalkeysolutions.net/records/483/kem-medical-products-corp/75775f7f-d4f9-47e5-b237-c4af74083468

> FDA 483 for Kem Medical Products Corp on July 21, 2022. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Kem Medical Products Corp
- Inspection Date: 2022-07-21
- Product Type: device
- Office Name: Division of Human and Animal Food Operations - East I
- Summary: Kem Medical Products Corp in Hauppauge, NY, was inspected by the FDA, resulting in two observations. The inspection revealed deficiencies in establishing procedures for finished device control and distribution, specifically regarding incoming inspection, and inadequate maintenance of complaint files. These issues indicate a moderate level of non-compliance with quality system requirements for medical devices.

## Related Documents

- [483 - 2020-01-15](https://www.globalkeysolutions.net/records/483/kem-medical-products-corp/d29db142-9f8a-4e62-8980-30c4628a49bc)

## Related Officers

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

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