Kath Khemicals LLC
FDA inspection history in Macomb, Michigan, 2025
- 1
- Warning letter
- 1
- Form 483
Every document, by year
- Warning letter
- Form 483
2025: one warning letter and one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2025One warning letter and one Form 483, at Macomb, Michigan.
Cited most
Across all Kath Khemicals observations on file
- 21 CFR 211.188Batch production and control records2
- 21 CFR 211.100(a)Written procedures; deviations1
- 21 CFR 211.165(a)Testing and release for distribution1
- 21 CFR 211.166(a)Stability testing1
- 21 CFR 211.180(e)(2)General requirements1
The complete Kath Khemicals 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
Macomb, Michigan
One warning letter and one Form 483 · 2025 · 9 observations
Latest: Warning letter, Sep 22, 2025 →
Documents
2 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2025-09-22 | Warning letter Warning letter | Macomb, Michigan | — | $99 |
| 2025-04-03 | 483 Form 483 | Macomb, Michigan | 9 | $99 |
Investigators on these documents
FEI number 3000719870 · most recent document Sep 22, 2025
About Kath Khemicals LLC
How many FDA Form 483s has Kath Khemicals LLC received?
FDA Intel has 1 Form 483 on file for Kath Khemicals LLC; the most recent is dated Apr 3, 2025.
When was Kath Khemicals LLC last inspected by FDA?
The most recent FDA inspection document on file for Kath Khemicals LLC is a Form 483 dated Apr 3, 2025, for the site in Macomb, Michigan.
What did FDA cite at Kath Khemicals LLC?
The regulations cited most in the observations on file for Kath Khemicals LLC are 21 CFR 211.188 (Batch production and control records), 2 times; 21 CFR 211.100(a) (Written procedures; deviations), 1 time; 21 CFR 211.165(a) (Testing and release for distribution), 1 time.
Has Kath Khemicals LLC received an FDA warning letter?
Yes. FDA Intel has 1 FDA warning letter on file for Kath Khemicals LLC; the most recent is dated Sep 22, 2025.