FDA Inspection
Confab Laboratories Inc.Confab Laboratories Inc. – FDA Inspection, Dec 1, 2017
Record Details
This FDA Inspection record concerns Confab Laboratories Inc., with an inspection on December 1, 2017, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · 9d899412-88b7-4c78-b563-984f2b9f34dd
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1032527
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
5- 21 CFR 211.68(b)Computer control of master formula records
- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.42(c)(2)Rejected Material Area
- 21 CFR 211.192Investigations of discrepancies, failures
- 21 CFR 211.22(d)Procedures not in writing, fully followed
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Other FDA inspections of Confab Laboratories Inc.
7| Date | Classification | Office | Project area |
|---|---|---|---|
| February 21, 2025 | NAI | Center for Food Safety and Applied Nutrition | Food Composition, Standards, Labeling and Econ |
| February 3, 2023 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| October 30, 2015 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| October 24, 2014 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| June 7, 2013 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Confab Laboratories Inc.
- FDA Inspection 1254270 - 2025-02-21
- FDA Inspection 1199219 - 2023-02-03
- FDA Inspection 948793 - 2015-10-30
- FDA Inspection 906516 - 2014-10-24
- FDA Inspection 840459 - 2013-06-07
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