FDA Inspection
Island Kinetics, Inc. d.b.a. CoValence LaboratoriesIsland Kinetics, Inc. d.b.a. CoValence Laboratories – FDA Inspection, Jan 23, 2026
Record Details
This FDA Inspection record concerns Island Kinetics, Inc. d.b.a. CoValence Laboratories, with an inspection on January 23, 2026, issued by the Denver District Office, covering human drugs.
- Inspection Date
- January 23, 2026
- Product Type
- Human Drugs
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ID · cbf6dfb7-237e-4ca3-8338-7c8bd89c5831
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1299522
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
4- 21 CFR 211.100(a)Absence of Written Procedures
- 21 CFR 211.192Investigations of discrepancies, failures
- 21 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
- 21 CFR 211.68(a)Calibration/Inspection/Checking not done
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Island Kinetics, Inc. d.b.a. CoValence Laboratories
5| Date | Classification | Office | Project area |
|---|---|---|---|
| January 6, 2020 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| September 2, 2016 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| May 16, 2012 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| April 21, 2011 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| June 16, 2010 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Island Kinetics, Inc. d.b.a. CoValence Laboratories
- FDA Inspection 1114441 - 2020-01-06
- FDA Inspection 984596 - 2016-09-02
- FDA Inspection 781937 - 2012-05-16
- FDA Inspection 721961 - 2011-04-21
- FDA Inspection 673188 - 2010-06-16
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