# FDA 483 - Kal-Med LLC - March 31, 2023

Source: https://www.globalkeysolutions.net/records/483/kal-med-llc/81920716-8706-480c-85a9-185563887fca

> FDA 483 for Kal-Med LLC on March 31, 2023. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Kal-Med LLC
- Inspection Date: 2023-03-31
- Product Type: device
- Office Name: FDA District Office — Stoneham, Massachusetts
- Summary: Kal-Med LLC, a medical device specification developer in Kensington, CT, was inspected by the FDA. The inspection revealed significant deficiencies in quality system procedures, including inadequate controls for purchased products and services, incomplete device history records lacking unique device identifiers, and a failure to establish proper procedures for design changes, particularly concerning product packaging.

## Related Officers

- [Power Trader/Data Scientist](https://www.globalkeysolutions.net/people/jeffrey-j-thibodeau/62b74030-4aef-400b-8ae2-8bf84712d813)

Company: https://www.globalkeysolutions.net/companies/kal-med-llc/71b30747-a002-450f-a676-a3992bc3c003

Office: https://www.globalkeysolutions.net/offices/fda-district-office-stoneham-massachusetts/1daceb4f-4057-46cf-af02-d4ccde44dcc7