FDA Inspection
ICU Medical IncICU Medical Inc – FDA Inspection, Sep 20, 2024
Record Details
This FDA Inspection record concerns ICU Medical Inc, with an inspection on September 20, 2024, issued by the Dallas District Office, covering human drugs.
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ID · 00f29ac8-ff3e-4eac-9a86-519c4214a8d6
Inspection Facts
- Inspection number
- 1230651
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
10- 21 CFR 211.105(b)Distinctive ID or code not recorded in batch record
- 21 CFR 211.113(b)Procedures for sterile drug products
- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.166(a)Written program not followed
- 21 CFR 211.166(a)(1)Sample size - test intervals
- 21 CFR 211.192Written record of investigation incomplete
- 21 CFR 211.194(d)Laboratory equipment calibration records
- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 211.42(c)(1)Incoming material area
- FDCA 582(b)(4)Systems in place to comply with verification requirements
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Other FDA inspections of ICU Medical Inc
6| Date | Classification | Office | Project area |
|---|---|---|---|
| June 28, 2024 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| March 10, 2017 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| May 23, 2014 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| August 24, 2012 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| April 27, 2011 | OAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for ICU Medical Inc
- FDA Inspection 1243793 - 2024-06-28
- FDA Inspection 1009809 - 2017-03-10
- FDA Inspection 880543 - 2014-05-23
- FDA Inspection 796073 - 2012-08-24
- FDA Inspection 723658 - 2011-04-27
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