# FDA 483 - ICU Medical Inc - September 20, 2024

Source: https://www.keypedia.com/records/483/icu-medical-inc/5db0b0cd-f781-4a32-aeac-1f4460f82c3a

> FDA 483 for ICU Medical Inc on September 20, 2024. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: ICU Medical Inc
- Inspection Date: 2024-09-20
- Product Type: drugs
- Office Name: Dallas District Office
- Summary: ICU Medical Inc. received a Form 483 citing ten observations primarily related to quality control, stability testing, and laboratory practices. Deficiencies included inadequate document control, unapproved logbooks, issues with stability study execution and environmental monitoring, and failures in microbiological contamination prevention. The firm also lacked thorough investigation procedures for out-of-specification results, had deficiencies in laboratory instrument qualification, and failed to comply with Drug Supply Chain Security Act verification requirements.

## Related Documents

- [483 - 2012-08-24](https://www.keypedia.com/records/483/icu-medical-inc/d75ba74b-5f0f-4e25-8bb8-e9daba78a0a2)

## Related Officers

- [Santos E. Camara](https://www.keypedia.com/people/santos-e-camara/18cea942-f6f9-4dec-9ce9-1c01c39009ce)
- [Miguel A. Martinez](https://www.keypedia.com/people/miguel-a-martinez/62e722b2-30bd-4671-9db9-8f089093e5a5)

Company: https://www.keypedia.com/companies/icu-medical-inc/007b8fa8-5781-4269-b963-3f0a6fbe5362

Office: https://www.keypedia.com/offices/dallas-district-office/2d1ee9ae-c44c-4494-8186-a920a69b98f9