Kath Khemicals LLC
Form 483 issued April 3, 2025 · Macomb, Michigan
- Inspection
- Mar 31 – Apr 3, 2025
- Investigators
- Nicholas J. Presto· Shannon L. Maisano
- Observations
- 9
- Pages
- 5
- FEI number
- 3000719870
In short: On April 3, 2025, FDA issued a Form 483 with 9 observations to Kath Khemicals LLC in Macomb, Michigan (FEI 3000719870) after an inspection that ran Mar 31 – Apr 3, 2025. The investigators were Nicholas J. Presto and Shannon L. Maisano. Most observations concern quality system and production; the most-cited regulation is 21 CFR 211.188 (batch production and control records).
At a glance
Quality system and production account for 6 of 9 observations.
What FDA observed
Preview: the opening words of each observation- 01
There is no quality…
- 02
The identity of each component of a drug product is not verified by conducting at least…
- 03
Testing and release of drug product for distribution do not include appropriate laboratory determination of satisfactory…
- 04
Your firm failed to establish written procedures for production and process controls designed to assure that…
This inspection in context
Nicholas J. Presto
10 documents · 2023–2026
Cites 211.188 (batch production and control records) more than any other section. Most of their documents are for sites in Michigan.
The firmKath Khemicals LLC 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(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Kath Khemicals LLC?
FDA listed 9 observations on this Form 483, mostly about quality system, production and laboratory controls. The most-cited regulation is 21 CFR 211.188 (batch production and control records). The opening words of each observation are shown on this page.
Who inspected Kath Khemicals LLC?
Nicholas J. Presto and Shannon L. Maisano are named on this Form 483, for the inspection of Mar 31 – Apr 3, 2025. Each investigator has a profile showing what they cite most.
When was Kath Khemicals LLC inspected by FDA?
The inspection ran Mar 31 – Apr 3, 2025, and the Form 483 is dated April 3, 2025.
How do I get the full Form 483 for Kath Khemicals LLC?
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.