# FDA 483 - Norfolk Medical Products, Inc. - July 26, 2022

Source: https://www.keypedia.com/records/483/norfolk-medical-products-inc/f8021711-cd6a-4725-84a7-e01ded32cd39

> FDA 483 for Norfolk Medical Products, Inc. on July 26, 2022. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Norfolk Medical Products, Inc.
- Inspection Date: 2022-07-26
- Product Type: device
- Office Name: Chicago District Office
- Summary: Norfolk Medical Products Inc, a medical device manufacturer in Skokie, IL, underwent an FDA inspection that identified a critical issue. The firm failed to document equipment calibrations, specifically for a heat sealer used in the manufacturing of sterilized needles. This lapse raises concerns about the integrity and sterility of their Class II medical devices.

## Related Officers

- [Investigator](https://www.keypedia.com/people/shafiq-s-ahadi/dd146b0a-ca1c-4052-8f50-4d68e14ad73f)

Company: https://www.keypedia.com/companies/norfolk-medical-products-inc/a2db596b-8351-4825-84cf-ed707065318d

Office: https://www.keypedia.com/offices/chicago-district-office/a510300b-0eaf-4a33-90b5-231d95977669