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# Letter Gives FDA Cleaning Validation Expectation: ECA
- URL: https://www.fdaweb.com/letter-gives-fda-cleaning-validation-expectation-eca/
- Published: 2019-06-05T12:00:00.000Z
- Updated: 2026-09-15T01:30:56.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5144261

ECA Academy says a recent FDA Warning Letter “gives very nice insights into the state of the art regarding cleaning validation from the point of view of FDA.” The [Warning Letter](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/laboratoires-clarins-568157-04232019?ref=fdaweb.com) was issued 4/23 to Laboratoires Clarins, Pontoise, France.

The ECA [analysis](https://www.gmp-compliance.org/gmp-news/cgmp-cleaning-validation-fdas-current-requirements?utm%5Fsource=twitter&utm%5Fmedium=news&utm%5Fcampaign=7270) says the agency criticized that the company could not demonstrate that contaminants could be removed with the cleaning/disinfection procedures used. It says the only measure applied was visual inspection of surfaces.

In its response, ECA says, the company provided an overview of its cleaning validation strategy and timelines for implementation. FDA said the response contained too little specifics and no rationale for its cleaning validation approach. FDA requested: 

- an extensive plan evaluating cleaning/disinfection procedures and activities;
- scientific rationale for the cleaning/disinfection validation strategy; and
- a summary of cleaning/disinfection validation protocol updates including worst-case scenarios.

FDA also requested a summary of updated standard operating procedures to ensure that an appropriate program for verification and validation of cleaning/disinfection procedures was in place when requested, ECA reports.