Kingchem Laboratories Inc.
Form 483 issued October 20, 2017 · St. Francis, Wisconsin
- Inspection
- Oct 16 – Oct 20, 2017
- Investigator
- Tenzin Jangchup
- Observations
- 6
- Pages
- 4
- FEI number
- 2129414
In short: On October 20, 2017, FDA issued a Form 483 with 6 observations to Kingchem Laboratories Inc. in St. Francis, Wisconsin (FEI 2129414) after an inspection that ran Oct 16 – Oct 20, 2017. The investigator was Tenzin Jangchup. Most observations concern quality system and materials.
At a glance
Quality system and materials account for 4 of 6 observations.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
The responsibilities and procedures applicable and assigned to the quality control unit…
- 02
Written records of investigations into unexplained discrepancies do not always include…
- 03
Sampling of raw materials is not conducted under appropriate location(s) and condition(s)…
- 04
Product quality reviews were not completed…
This inspection in context
Tenzin Jangchup
14 documents · 2015–2019
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in Minnesota.
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 6 observations on this Form 483, mostly about quality system, materials and laboratory controls. The opening words of each observation are shown on this page.
Who inspected Kingchem Laboratories Inc.?
Tenzin Jangchup is named on this Form 483, for the inspection of Oct 16 – Oct 20, 2017. Each investigator has a profile showing what they cite most.
When was Kingchem Laboratories Inc. inspected by FDA?
The inspection ran Oct 16 – Oct 20, 2017, and the Form 483 is dated October 20, 2017.
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.