Ecolab Inc.
Form 483 issued June 24, 2016 · Huntington, Indiana
- Inspection
- Jun 20 – Jun 24, 2016
- Investigators
- Emilie Kahn· Robert M. Barbosa
- Observations
- 4
- Pages
- 6
- FEI number
- 1810414
In short: On June 24, 2016, FDA issued a Form 483 with 4 observations to Ecolab Inc. in Huntington, Indiana (FEI 1810414) after an inspection that ran Jun 20 – Jun 24, 2016. The investigators were Emilie Kahn and Robert M. Barbosa. Most observations concern laboratory controls and production.
At a glance
Observations span 4 systems, led by laboratory controls.
What FDA observed
Preview: the opening words of each observation- 01
Results of stability testing are not used…
- 02
Control procedures are not established which validate the performance of those manufacturing processes that may be…
- 03
Equipment for adequate control over humidity and temperature is not provided when appropriate for the manufacture…
- 04
Drug product component testing is deficient in that at least one specific test to verify the…
This inspection in context
Emilie Kahn
15 documents · 2016–2019
Cites 211.22 (responsibilities of quality control unit) more than any other section. Most of their documents are for sites in Michigan.
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 211.166(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Ecolab Inc.?
FDA listed 4 observations on this Form 483, mostly about laboratory controls, production and facilities & equipment. The opening words of each observation are shown on this page.
Who inspected Ecolab Inc.?
Emilie Kahn and Robert M. Barbosa are named on this Form 483, for the inspection of Jun 20 – Jun 24, 2016. Each investigator has a profile showing what they cite most.
When was Ecolab Inc. inspected by FDA?
The inspection ran Jun 20 – Jun 24, 2016, and the Form 483 is dated June 24, 2016.
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.