# FDA 483 - Brenntag Great Lakes, LLC - August 02, 2019

Source: https://www.keypedia.com/records/483/brenntag-great-lakes-llc/ce6894a4-b91c-4835-a229-072d15ae20bb

> FDA 483 for Brenntag Great Lakes, LLC on August 02, 2019. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Brenntag Great Lakes, LLC
- Inspection Date: 2019-08-02
- Product Type: drugs
- Office Name: Minneapolis District Office
- Summary: An FDA inspection of Brenntag Great Lakes, LLC in Menomonee Falls, WI, revealed significant deficiencies in the manufacture of OTC drug blends. The firm was cited for unvalidated cleaning procedures for blending tanks, a lack of written production and process controls including blending process validation and documentation of critical parameters, and the absence of a stability program for OTC products. Many of these issues were repeat observations from previous inspections, indicating persistent non-compliance.

## Related Documents

- [483 - 2023-05-05](https://www.keypedia.com/records/483/brenntag-great-lakes-llc/0f77baf6-9caf-4960-aeb7-c58ecd8822a1)

## Related Officers

- [Vaishali J. Patel](https://www.keypedia.com/people/vaishali-j-patel/3d515b84-e0fd-4f96-914c-f7f09e2de307)
- [Michele L. Glendenning](https://www.keypedia.com/people/michele-l-glendenning/a3c23a43-634c-4140-807b-c17fbc03bb00)

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