Island Kinetics, Inc. d.b.a. CoValence Laboratories
FDA inspection history in Chandler, Arizona, 2020 to 2026
- 1
- Warning letter
- 1
- Form 483
Every document, by year
- Warning letter
- Form 483
2020: one Form 483; 2026: one warning letter.
The story so far
Built from the dates and citations on the documents themselves.
- 2020One Form 483, at Chandler, Arizona.
- 2026One warning letter, at Chandler, Arizona.
Cited most
Across all Island Kinetics, Inc. d.b.a. CoValence Laboratories observations on file
- 21 CFR 211.160(b)General requirements2
- 21 CFR 211.100(a)Written procedures; deviations1
- 21 CFR 211.110(a)Sampling and testing of in-process materials and drug products1
- 21 CFR 211.165(f)Testing and release for distribution1
- 21 CFR 211.188Batch production and control records1
The complete Island Kinetics, Inc. d.b.a. CoValence Laboratories file.
All 2 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
The price of the documents, added to your cart together
Sites
Chandler, Arizona
One warning letter and one Form 483 · 2020 to 2026 · 13 observations
Latest: Warning letter, Jul 16, 2026 →
Documents
2 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2026-07-16 | Warning letter Warning letter | Chandler, Arizona | — | $99 |
| 2020-01-06 | 483 Form 483 | Chandler, Arizona | 13 | $99 |
Investigators on these documents
FEI number 3002408934 · most recent document Jul 16, 2026
About Island Kinetics, Inc. d.b.a. CoValence Laboratories
How many FDA Form 483s has Island Kinetics, Inc. d.b.a. CoValence Laboratories received?
FDA Intel has 1 Form 483 on file for Island Kinetics, Inc. d.b.a. CoValence Laboratories; the most recent is dated Jan 6, 2020.
When was Island Kinetics, Inc. d.b.a. CoValence Laboratories last inspected by FDA?
The most recent FDA inspection document on file for Island Kinetics, Inc. d.b.a. CoValence Laboratories is a Form 483 dated Jan 6, 2020, for the site in Chandler, Arizona.
What did FDA cite at Island Kinetics, Inc. d.b.a. CoValence Laboratories?
The regulations cited most in the observations on file for Island Kinetics, Inc. d.b.a. CoValence Laboratories are 21 CFR 211.160(b) (General requirements), 2 times; 21 CFR 211.100(a) (Written procedures; deviations), 1 time; 21 CFR 211.110(a) (Sampling and testing of in-process materials and drug products), 1 time.
Has Island Kinetics, Inc. d.b.a. CoValence Laboratories received an FDA warning letter?
Yes. FDA Intel has 1 FDA warning letter on file for Island Kinetics, Inc. d.b.a. CoValence Laboratories; the most recent is dated Jul 16, 2026.