Kingchem Laboratories Inc.
Form 483 issued October 22, 2021 · St. Francis, Wisconsin
- Inspection
- Oct 18 – Oct 22, 2021
- Investigators
- Charles L. Zhou· Gregory R. Brinsley· Lori B. Wikstrom
- Observations
- 1
- Pages
- 2
- FEI number
- 2129414
In short: On October 22, 2021, FDA issued a Form 483 with 1 observation to Kingchem Laboratories Inc. in St. Francis, Wisconsin (FEI 2129414) after an inspection that ran Oct 18 – Oct 22, 2021. The investigators were Charles L. Zhou, Gregory R. Brinsley and Lori B. Wikstrom. Most observations concern quality system; the most-cited regulation is 21 CFR 211.22 (responsibilities of quality control unit).
At a glance
1 of 1 observations on this 483 concern quality system.
Most cited: 21 CFR 211.22 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Documents related to the manufacture of APIs were not distributed…
This inspection in context
Charles L. Zhou
11 documents · 2016–2021
Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in Michigan.
The firmKingchem Laboratories Inc. history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.22
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Kingchem Laboratories Inc.?
FDA listed 1 observation on this Form 483, mostly about quality system. The most-cited regulation is 21 CFR 211.22 (responsibilities of quality control unit). The opening words of each observation are shown on this page.
Who inspected Kingchem Laboratories Inc.?
Charles L. Zhou, Gregory R. Brinsley and Lori B. Wikstrom are named on this Form 483, for the inspection of Oct 18 – Oct 22, 2021. Each investigator has a profile showing what they cite most.
When was Kingchem Laboratories Inc. inspected by FDA?
The inspection ran Oct 18 – Oct 22, 2021, and the Form 483 is dated October 22, 2021.
How do I get the full Form 483 for Kingchem Laboratories Inc.?
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.