FDA Inspection
Citra Labs, LLCCitra Labs, LLC – FDA Inspection, Sep 27, 2017
Record Details
This FDA Inspection record concerns Citra Labs, LLC, with an inspection on September 27, 2017, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · 53e32ddb-866e-4dbc-8714-179c9e0e1575
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1026851
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
4- 21 CFR 211.42(c)(10)(v)Cleaning System
- 21 CFR 211.186(b)(9)Manufacturing Instructions and Specifications
- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 211.182Written records kept in individual logs
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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 |
| 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 1232208 - 2024-03-08
- FDA Inspection 1114950 - 2019-12-13
- FDA Inspection 907313 - 2014-11-21
- FDA Inspection 883492 - 2014-06-13
- FDA Inspection 756503 - 2011-12-09
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