FDA Inspection
Island Kinetics, Inc. d.b.a. CoValence LaboratoriesIsland Kinetics, Inc. d.b.a. CoValence Laboratories – FDA Inspection, Jan 6, 2020
Record Details
This FDA Inspection record concerns Island Kinetics, Inc. d.b.a. CoValence Laboratories, with an inspection on January 6, 2020, issued by the Center for Drug Evaluation and Research, covering drugs.
- Inspection Date
- January 6, 2020
- Product Type
- Drugs
View Company Profile
ID · eca1963a-65fa-4a92-8261-02e6bb414acf
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1114441
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
13- 21 CFR 211.87Retest of approved components/containers/closures
- 21 CFR 211.188Prepared for each batch, include complete information
- 21 CFR 211.160(b)(3)Drug product sample
- 21 CFR 211.165(f)Failing drug products not rejected
- 21 CFR 211.25(a)Training--operations, GMPs, written procedures
- 21 CFR 211.84(d)(2)Establish reliability of supplier"s C of A
- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.68(a)Written calibration / inspection records not kept
- 21 CFR 211.100(a)Absence of Written Procedures
- 21 CFR 211.22(d)Procedures not in writing, fully followed
Showing 10 of 13 citations.
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 23, 2026 | OAI | Denver District Office | 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 1299522 - 2026-01-23
- FDA Inspection 984596 - 2016-09-02
- FDA Inspection 781937 - 2012-05-16
- FDA Inspection 721961 - 2011-04-21
- FDA Inspection 673188 - 2010-06-16
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.