# FDA 483 - Ecolab, Inc. - November 09, 2018

Source: https://www.keypedia.com/records/483/ecolab-inc/1a7393bb-1bc6-4f9c-b66a-08b3e004e81c

> FDA 483 for Ecolab, Inc. on November 09, 2018. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Ecolab, Inc.
- Inspection Date: 2018-11-09
- Product Type: drugs
- Office Name: Division of Pharmaceutical Quality Operations III
- Summary: An FDA inspection of Eco-Lab, Inc. in Huntington, IN, revealed significant quality system deficiencies. The firm failed to thoroughly investigate unexplained discrepancies, including microbial contamination in water used for drug products and out-of-specification stability chamber conditions. Additionally, the inspection cited a lack of established procedures for preventing objectionable microorganisms and inadequate second-person review of laboratory records.

## Related Documents

- [483 - 2018-11-09](https://www.keypedia.com/records/483/ecolab-inc/c89c814d-53df-4a25-a888-861ee56fa1da)
- [483 - 2025-06-05](https://www.keypedia.com/records/483/ecolab-inc/67603eda-3533-4b52-ad21-4c38425f0c4c)

## Related Officers

- [Investigator](https://www.keypedia.com/people/sarah-e-rhoades/d965990c-15cc-4722-b2d0-aea7206c71b0)

Company: https://www.keypedia.com/companies/ecolab-inc/b1f974bf-f8ce-4704-bbe7-2b1cc3d35c03

Office: https://www.keypedia.com/offices/division-of-pharmaceutical-quality-operations-iii/45bc2d0d-d731-4955-aeb5-59aa0b76e4f0