ISP Chemicals LLC
Form 483 issued December 10, 2021 · Columbus, Ohio
- Investigator
- Ucheabuchi C. Chudi-Nwankwor
- Observations
- 4
- Pages
- 5
- FEI number
- 1525964
In short: On December 10, 2021, FDA issued a Form 483 with 4 observations to ISP Chemicals LLC in Columbus, Ohio (FEI 1525964). The investigator was Ucheabuchi C. Chudi-Nwankwor. Most observations concern laboratory controls and quality system; the most-cited regulation is 21 CFR 211.22 (responsibilities of quality control unit).
At a glance
Laboratory controls and quality system account for 3 of 4 observations.
Most cited: 21 CFR 211.22 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
The accuracy, sensitivity, specificity, and reproducibility of test methods have not…
- 02
Your firm failed to follow an adequate written testing program designed to assess the stability characteristics…
- 03
Quality Control unit lacks the authority to review production and analytical records to ensure…
- 04
The Quality Control unit lacked the responsibility to…
This inspection in context
Ucheabuchi C. Chudi-Nwankwor
22 documents · 2016–2026
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 211.22
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at ISP Chemicals LLC?
FDA listed 4 observations on this Form 483, mostly about laboratory controls, quality system and materials. The most-cited regulation is 21 CFR 211.22 (responsibilities of quality control unit). The opening words of each observation are shown on this page.
Who inspected ISP Chemicals LLC?
Ucheabuchi C. Chudi-Nwankwor is named on this Form 483. Each investigator has a profile showing what they cite most.
When was ISP Chemicals LLC inspected by FDA?
This Form 483 is dated December 10, 2021.
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.