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

Source: https://www.keypedia.com/records/483/ecolab-inc/c89c814d-53df-4a25-a888-861ee56fa1da

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

---

## Details

- Record Type: 483
- Company Name: Ecolab, Inc.
- Inspection Date: 2018-11-09
- Product Type: drugs
- Office Name: Detroit District Office
- Summary: An FDA inspection of Ecolab, Inc.'s manufacturing facility in Huntington, Indiana, conducted from November 5-9, 2018, identified significant deviations from established manufacturing practice standards. The observations primarily concerned the company's quality and laboratory systems. Key issues included a failure to thoroughly investigate unexplained discrepancies and out-of-specification events, such as repeated instances of *Pseudomonas aeruginosa* or *Burkholderia cepacia* contamination in USP Purified Water samples from 2017-2018, which affected numerous distributed drug product lots. Additionally, the firm did not adequately investigate out-of-specification stability chamber conditions or several internal non-conformances. The inspection also highlighted inadequate procedures for preventing objectionable microorganisms in non-sterile drug products, specifically lacking scientifically sound methods for microbial identification in purified water and proper controls for laboratory growth media. Furthermore, a critical absence of independent review was noted in laboratory records, with raw material testing, product release, and purified water sample data not undergoing verification by a second qualified individual. Ecolab, Inc. is required to implement comprehensive corrective actions and provide a detailed response to the FDA to address these findings and ensure compliance with manufacturing regulations.

## Related Documents

- [483 - 2018-11-09](https://www.keypedia.com/records/483/ecolab-inc/1a7393bb-1bc6-4f9c-b66a-08b3e004e81c)
- [483 - 2025-06-05](https://www.keypedia.com/records/483/ecolab-inc/67603eda-3533-4b52-ad21-4c38425f0c4c)

## Related Officers

- [Jose E. Almeida](https://www.keypedia.com/people/jose-e-almeida/1df7930c-d835-4c16-85a0-4c9adbb531a4)
- [Investigator](https://www.keypedia.com/people/sarah-e-rhoades/d965990c-15cc-4722-b2d0-aea7206c71b0)
- [Manager](https://www.keypedia.com/people/kevin-wiig/fd84df0a-944e-43b0-8f4b-18c5b20dcff7)

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

Office: https://www.keypedia.com/offices/detroit-district-office/b09a1815-a000-40c0-bb44-5432ce87ed03