Ecolab Inc.
Form 483 issued June 5, 2025 · Huntington, Indiana
- Inspection
- Jun 3 – Jun 5, 2025
- Investigator
- Andrew O. Ejiofor
- Observations
- 5
- Pages
- 5
- FEI number
- 1810414
In short: On June 5, 2025, FDA issued a Form 483 with 5 observations to Ecolab Inc. in Huntington, Indiana (FEI 1810414) after an inspection that ran Jun 3 – Jun 5, 2025. The investigator was Andrew O. Ejiofor. Most observations concern quality system and laboratory controls; the most-cited regulation is 21 CFR 211.22 (responsibilities of quality control unit).
At a glance
3 of 5 observations on this 483 concern quality system.
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 responsibilities and procedures applicable to the quality control unit are not in…
- 02
There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch…
- 03
Laboratory controls do not include the establishment of scientifically sound and appropriate specifications, standards, sampling plans…
- 04
The quality control unit lacks responsibility to approve and reject all procedures or specifications impacting on…
This inspection in context
Andrew O. Ejiofor
5 documents · 2024–2025
Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in Georgia.
The firmEcolab Inc. history
All 3 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 Ecolab Inc.?
FDA listed 5 observations on this Form 483, mostly about quality system, laboratory controls and production. 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 Ecolab Inc.?
Andrew O. Ejiofor is named on this Form 483, for the inspection of Jun 3 – Jun 5, 2025. Each investigator has a profile showing what they cite most.
When was Ecolab Inc. inspected by FDA?
The inspection ran Jun 3 – Jun 5, 2025, and the Form 483 is dated June 5, 2025.
How do I get the full Form 483 for Ecolab Inc.?
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.