FDA Inspection
Citra Labs, LLCCitra Labs, LLC – FDA Inspection, Jun 13, 2014
Record Details
This FDA Inspection record concerns Citra Labs, LLC, with an inspection on June 13, 2014, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Citra Labs, LLC
- Inspection Date
- June 13, 2014
- Product Type
- Drugs
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ID · 4545fe4d-3012-4273-8313-8e13021e70d1
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 883492
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
4- 21 CFR 211.42(a)Buildings of Suitable Size, Construction, Location
- 21 CFR 211.84(a)Components withheld from use pending release
- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.192Investigations of discrepancies, failures
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Other FDA inspections of Citra Labs, LLC
6| Date | Classification | Office | Project area |
|---|---|---|---|
| March 8, 2024 | VAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| 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 |
| December 9, 2011 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Citra Labs, LLC
- FDA Inspection 1232208 - 2024-03-08
- FDA Inspection 1114950 - 2019-12-13
- FDA Inspection 1026851 - 2017-09-27
- FDA Inspection 907313 - 2014-11-21
- FDA Inspection 756503 - 2011-12-09
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