# FDA 483 - Brenntag Great Lakes, LLC - May 05, 2023

Source: https://www.keypedia.com/records/483/brenntag-great-lakes-llc/0f77baf6-9caf-4960-aeb7-c58ecd8822a1

> FDA 483 for Brenntag Great Lakes, LLC on May 05, 2023. Product: drugs. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Brenntag Great Lakes, LLC
- Inspection Date: 2023-05-05
- Product Type: drugs
- Office Name: Minneapolis District Office
- Summary: Brenntag Great Lakes, LLC, a manufacturer in Menomonee Falls, WI, was cited for significant quality control deficiencies during an FDA inspection. The firm failed to ensure proper review and approval of batch records and changes, did not conduct annual product reviews for several products, and exhibited issues with process validation for hand sanitizer manufacturing. Additionally, the inspection revealed unvalidated cleaning procedures for shared equipment and inadequate controls over computerized systems, including the use of a common login for a Gas Chromatography system.

## Related Documents

- [483 - 2019-08-02](https://www.keypedia.com/records/483/brenntag-great-lakes-llc/ce6894a4-b91c-4835-a229-072d15ae20bb)

## Related Officers

- [Nibin Varghese](https://www.keypedia.com/people/nibin-varghese/43e17f63-2c1f-4d46-b26f-dc8ac8885438)

Company: https://www.keypedia.com/companies/brenntag-great-lakes-llc/358b4149-718f-4b81-86b8-11766e9f6185

Office: https://www.keypedia.com/offices/minneapolis-district-office/c79fc8dc-f884-48fc-ba80-2947f662511d