FDA Inspection
Citra Labs, LLCCitra Labs, LLC – FDA Inspection, Mar 8, 2024
Record Details
This FDA Inspection record concerns Citra Labs, LLC, with an inspection on March 8, 2024, issued by the Center for Biologics Evaluation and Research, covering biologics.
- People
- Jeremy L. Wally (Issuing Officer)
- Jonah S. Ufferfilge (FDA Associated Person)
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ID · ec472c96-1b5b-4acb-b495-7196ea749f6c
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1232208
- FDA center
- Biologics
- Project area
- Blood and Blood Products
FDA Citations
4- 21 CFR 211.58Buildings not maintained in good state of repair
- 21 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
- 21 CFR 211.67(b)Written procedures not established/followed
- 21 CFR 211.100(b)SOPs not followed / documented
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Citra Labs, LLC
6| Date | Classification | Office | Project area |
|---|---|---|---|
| December 13, 2019 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| September 27, 2017 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| November 21, 2014 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| June 13, 2014 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| December 9, 2011 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Citra Labs, LLC
- FDA Inspection 1114950 - 2019-12-13
- FDA Inspection 1026851 - 2017-09-27
- FDA Inspection 907313 - 2014-11-21
- FDA Inspection 883492 - 2014-06-13
- FDA Inspection 756503 - 2011-12-09
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