Island Kinetics, Inc. d.b.a. CoValence Laboratories
Form 483 issued January 6, 2020 · Chandler, Arizona
- Inspection
- Dec 16, 2019 – Jan 6, 2020
- Investigators
- Cnopner A. Emer· Cocoper A. Emer
- Observations
- 13
- Pages
- 12
- FEI number
- 3002408934
In short: On January 6, 2020, FDA issued a Form 483 with 13 observations to Island Kinetics, Inc. d.b.a. CoValence Laboratories in Chandler, Arizona (FEI 3002408934) after an inspection that ran Dec 16, 2019 – Jan 6, 2020. The investigators were Cnopner A. Emer and Cocoper A. Emer. Most observations concern laboratory controls and materials; the most-cited regulation is 21 CFR 211.160 (general requirements).
At a glance
Observations span 4 systems, led by laboratory controls.
What FDA observed
Preview: the opening words of each observation- 01
Drug products failing to meet established specifications and quality control…
- 02
The responsibilities and procedures applicable to the quality control unit are not in…
- 03
Approved components are not retested or reexamined as appropriate for identity, strength, quality and purity after…
- 04
Written procedures are not established that describe the in-process controls to be conducted on appropriate samples…
This inspection in context
Cnopner A. Emer
1 document · 2020
Cites 211.160(b) (general requirements) more than any other section. Most of their documents are for sites in Arizona.
The firmIsland Kinetics, Inc. d.b.a. CoValence Laboratories history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.165(f)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Island Kinetics, Inc. d.b.a. CoValence Laboratories?
FDA listed 13 observations on this Form 483, mostly about laboratory controls, materials and production. The most-cited regulation is 21 CFR 211.160 (general requirements). The opening words of each observation are shown on this page.
Who inspected Island Kinetics, Inc. d.b.a. CoValence Laboratories?
Cnopner A. Emer and Cocoper A. Emer are named on this Form 483, for the inspection of Dec 16, 2019 – Jan 6, 2020. Each investigator has a profile showing what they cite most.
When was Island Kinetics, Inc. d.b.a. CoValence Laboratories inspected by FDA?
The inspection ran Dec 16, 2019 – Jan 6, 2020, and the Form 483 is dated January 6, 2020.
How do I get the full Form 483 for Island Kinetics, Inc. d.b.a. CoValence Laboratories?
Download the original PDF from FDA Intel for $99, with no subscription. Your first Form 483 or letter is on us. You also get an invoice PDF with the order.