Kingchem Laboratories Inc.
FDA inspection history in St. Francis, Wisconsin, 2017 to 2021
- 2
- Form 483s
Every document, by year
- Form 483
2017: one Form 483; 2021: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2017One Form 483, at St. Francis, Wisconsin.
- 2017The longest 483 on file: 6 observations over 4 pages at St. Francis, Wisconsin.
- 2021One Form 483, at St. Francis, Wisconsin.
Cited most
Across all Kingchem Laboratories observations on file
- 21 CFR 211.22Responsibilities of quality control unit2
- 21 CFR 211.166Stability testing1
- 21 CFR 211.180General requirements1
- 21 CFR 211.192Production record review1
- 21 CFR 211.84Testing and approval or rejection of components, drug product containers, and closures1
The complete Kingchem 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
St. Francis, Wisconsin
Two Form 483s · 2017 to 2021 · 7 observations
Latest: Form 483, Oct 22, 2021 →
Documents
2 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2021-10-22 | 483 Form 483 | St. Francis, Wisconsin | 1 | $99 |
| 2017-10-20 | 483 Form 483 | St. Francis, Wisconsin | 6 | $99 |
Investigators on these documents
Charles L. Zhou (1)Gregory R. Brinsley (1)Lori B. Wikstrom (1)Tenzin Jangchup (1)
FEI number 2129414 · most recent document Oct 22, 2021
About Kingchem Laboratories Inc.
How many FDA Form 483s has Kingchem Laboratories Inc. received?
FDA Intel has 2 Form 483s on file for Kingchem Laboratories Inc.; the most recent is dated Oct 22, 2021.
When was Kingchem Laboratories Inc. last inspected by FDA?
The most recent FDA inspection document on file for Kingchem Laboratories Inc. is a Form 483 dated Oct 22, 2021, for the site in St. Francis, Wisconsin.
What did FDA cite at Kingchem Laboratories Inc.?
The regulations cited most in the observations on file for Kingchem Laboratories Inc. are 21 CFR 211.22 (Responsibilities of quality control unit), 2 times; 21 CFR 211.166 (Stability testing), 1 time; 21 CFR 211.180 (General requirements), 1 time.