FDA Intel

Ecolab Inc.

Form 483 issued November 9, 2018 · Huntington, Indiana

Inspection
Nov 5 – Nov 9, 2018
Investigator
Sarah E. Rhoades
Observations
3
Pages
5
FEI number
1810414

In short: On November 9, 2018, FDA issued a Form 483 with 3 observations to Ecolab Inc. in Huntington, Indiana (FEI 1810414) after an inspection that ran Nov 5 – Nov 9, 2018. The investigator was Sarah E. Rhoades. Most observations concern quality system and production.

At a glance

Quality system and production account for 2 of 3 observations.

Quality system1
Production1
Laboratory controls1

What FDA observed

Preview: the opening words of each observation
  1. 01
    21 CFR 211.192

    There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch…

  2. 02
    21 CFR 211.113(a)

    Procedures designed to prevent objectionable microorganisms in drug products not required to be…

  3. 03
    21 CFR 211.194(a)(8)

    Laboratory records do not include the initials or signature of a second person showing that the…

The full 483

Plus the full detail behind each one, exactly as FDA wrote it.

Get the full 483

This inspection in context

The investigator

Sarah E. Rhoades

14 documents · 2017–2021

Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in Michigan.

The firm

Ecolab Inc. history

All 3 documents on file for this site, in date order, with what was cited at each inspection.

Similar 483s

Other sites cited under 211.192

See how FDA wrote the same problem up elsewhere.

Questions about this 483

What did FDA find at Ecolab Inc.?

FDA listed 3 observations on this Form 483, mostly about quality system, production and laboratory controls. The opening words of each observation are shown on this page.

Who inspected Ecolab Inc.?

Sarah E. Rhoades is named on this Form 483, for the inspection of Nov 5 – Nov 9, 2018. Each investigator has a profile showing what they cite most.

When was Ecolab Inc. inspected by FDA?

The inspection ran Nov 5 – Nov 9, 2018, and the Form 483 is dated November 9, 2018.

How do I get the full Form 483 for Ecolab Inc.?

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