FDA-Inspected Site

Island Kinetics, Inc. d.b.a. CoValence Laboratories

9 FDA inspections are on record for Island Kinetics, Inc. d.b.a. CoValence Laboratories in Chandler, United States.

483· Form 483 issued

Chandler, United States · Last updated August 15, 2026

Overview

  • 9 FDA inspections are on record.
  • 4 inspections produced a Form 483.
  • The most recent recorded inspection date is 2026-01-23.

At a glance

Inspections

9

Form 483s

4

EIRs

0

Last outcome

Form 483

Inspection history

FDA inspections on record, most recent first.

InspectionCategoryOutcomeForm 483
14 Jan 2026 – 23 Jan 2026Human DrugsWLView 483 →
16 Dec 2019 – 6 Jan 2020Human Drugs483View 483 →
29 Aug 2016 – 2 Sep 2016Human Drugs483View 483 →
16 May 2012Not recordedClean
21 Apr 2011Not recordedClean
16 Jun 2010Not recordedClean
23 Jun 2008Not recorded483On file
12 Nov 2004Not recordedClean
20 Sep 2001Not recordedClean

Observations on record

Form 483 observations cited at this site, most recent first.

23 Jan 2026
21 CFR 211.100(a)

Absence of Written Procedures

Cited by Nicholas L Hunt, Hung H Do

23 Jan 2026
21 CFR 211.192

Investigations of discrepancies, failures

Cited by Nicholas L Hunt, Hung H Do

23 Jan 2026
21 CFR 211.67(a)

Cleaning / Sanitizing / Maintenance

Cited by Nicholas L Hunt, Hung H Do

23 Jan 2026
21 CFR 211.68(a)

Calibration/Inspection/Checking not done

Cited by Nicholas L Hunt, Hung H Do

6 Jan 2020
21 CFR 211.100(a)

Absence of Written Procedures

Cited by Christopher M Jenner, Zachary A Bogorad

Investigators

FDA investigators tied to this site in the record.

Recurring citations

CFR citation patterns observed across this site's inspections.

CitationWhat it coversCited
21 CFR 211.100(a)Cited across public-safe Form 483 observations3x
21 CFR 211.68(a)Cited across public-safe Form 483 observations3x
21 CFR 211.110(a)Cited across public-safe Form 483 observations2x
21 CFR 211.160(b)(3)Cited across public-safe Form 483 observations2x
21 CFR 211.192Cited across public-safe Form 483 observations2x
21 CFR 211.105(a)Cited across public-safe Form 483 observations1x
21 CFR 211.160(a)Cited across public-safe Form 483 observations1x
21 CFR 211.160(b)Cited across public-safe Form 483 observations1x
21 CFR 211.165(f)Cited across public-safe Form 483 observations1x
21 CFR 211.166(a)(3)Cited across public-safe Form 483 observations1x
21 CFR 211.186(b)(9)Cited across public-safe Form 483 observations1x
21 CFR 211.188Cited across public-safe Form 483 observations1x
21 CFR 211.22(a)Cited across public-safe Form 483 observations1x
21 CFR 211.22(d)Cited across public-safe Form 483 observations1x
21 CFR 211.25(a)Cited across public-safe Form 483 observations1x
21 CFR 211.28(a)Cited across public-safe Form 483 observations1x
21 CFR 211.56(b)Cited across public-safe Form 483 observations1x
21 CFR 211.67(a)Cited across public-safe Form 483 observations1x
21 CFR 211.67(b)Cited across public-safe Form 483 observations1x
21 CFR 211.67(c)Cited across public-safe Form 483 observations1x
21 CFR 211.80(a)Cited across public-safe Form 483 observations1x
21 CFR 211.84(a)Cited across public-safe Form 483 observations1x
21 CFR 211.84(c)(4)Cited across public-safe Form 483 observations1x
21 CFR 211.84(d)(1)Cited across public-safe Form 483 observations1x
21 CFR 211.84(d)(2)Cited across public-safe Form 483 observations1x
21 CFR 211.87Cited across public-safe Form 483 observations1x

Full site report

Get the verbatim findings behind this site's 4 Form 483s

Source PDFs, verbatim observations, and recurring CFR citations, so your team knows what this site gets cited for.

  • The site's full inspection history, with every Form 483 and its outcome
  • Warning letters and recalls tied to the company behind it
  • Whether recurring CFR citations get closed out or repeat