ISP Chemicals LLC
Form 483 issued January 29, 2024 · Columbus, Ohio
- Inspection
- Jan 17 – Jan 29, 2024
- Investigators
- Geoffrey K. Kilili· Travis V. Hull
- Observations
- 1
- Pages
- 3
- FEI number
- 1525964
In short: On January 29, 2024, FDA issued a Form 483 with 1 observation to ISP Chemicals LLC in Columbus, Ohio (FEI 1525964) after an inspection that ran Jan 17 – Jan 29, 2024. The investigators were Geoffrey K. Kilili and Travis V. Hull. Most observations concern laboratory controls; the most-cited regulation is 21 CFR 211.166 (stability testing).
At a glance
1 of 1 observations on this 483 concern laboratory controls.
Most cited: 21 CFR 211.166 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
The methods used during the stability testing of Flunixin Meglumine and Mitotane since 1996 has not…
This inspection in context
Geoffrey K. Kilili
7 documents · 2021–2025
Cites 211.22 (responsibilities of quality control unit) more than any other section. Most of their documents are for sites in Ohio.
The firmISP Chemicals 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 211.166
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at ISP Chemicals LLC?
FDA listed 1 observation on this Form 483, mostly about laboratory controls. The most-cited regulation is 21 CFR 211.166 (stability testing). The opening words of each observation are shown on this page.
Who inspected ISP Chemicals LLC?
Geoffrey K. Kilili and Travis V. Hull are named on this Form 483, for the inspection of Jan 17 – Jan 29, 2024. Each investigator has a profile showing what they cite most.
When was ISP Chemicals LLC inspected by FDA?
The inspection ran Jan 17 – Jan 29, 2024, and the Form 483 is dated January 29, 2024.
How do I get the full Form 483 for ISP Chemicals 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.