ISP Chemicals LLC
FDA inspection history in Columbus, Ohio, 2021 to 2024
- 2
- Form 483s
Every document, by year
- Form 483
2021: one Form 483; 2024: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2021One Form 483, at Columbus, Ohio.
- 2021The longest 483 on file: 4 observations over 5 pages at Columbus, Ohio.
- 2024One Form 483, at Columbus, Ohio.
Cited most
Across all ISP Chemicals observations on file
- 21 CFR 211.166Stability testing2
- 21 CFR 211.22Responsibilities of quality control unit2
- 21 CFR 211.165Testing and release for distribution1
- 21 CFR 211.188Batch production and control records1
- 21 CFR 211.84Testing and approval or rejection of components, drug product containers, and closures1
The complete ISP Chemicals 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
Columbus, Ohio
Two Form 483s · 2021 to 2024 · 5 observations
Latest: Form 483, Jan 29, 2024 →
Documents
2 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2024-01-29 | 483 Form 483 | Columbus, Ohio | 1 | $99 |
| 2021-12-10 | 483 Form 483 | Columbus, Ohio | 4 | $99 |
Investigators on these documents
Geoffrey K. Kilili (1)Travis V. Hull (1)Ucheabuchi C. Chudi-Nwankwor (1)
FEI number 1525964 · most recent document Jan 29, 2024
About ISP Chemicals LLC
How many FDA Form 483s has ISP Chemicals LLC received?
FDA Intel has 2 Form 483s on file for ISP Chemicals LLC; the most recent is dated Jan 29, 2024.
When was ISP Chemicals LLC last inspected by FDA?
The most recent FDA inspection document on file for ISP Chemicals LLC is a Form 483 dated Jan 29, 2024, for the site in Columbus, Ohio.
What did FDA cite at ISP Chemicals LLC?
The regulations cited most in the observations on file for ISP Chemicals LLC are 21 CFR 211.166 (Stability testing), 2 times; 21 CFR 211.22 (Responsibilities of quality control unit), 2 times; 21 CFR 211.165 (Testing and release for distribution), 1 time.