# FDA 483 - LBB Specialties Holdings LLC - June 26, 2019

Source: https://www.keypedia.com/records/483/lbb-specialties-holdings-llc/abec0deb-2306-4094-ab3f-668586677308

> FDA 483 for LBB Specialties Holdings LLC on June 26, 2019. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: LBB Specialties Holdings LLC
- Inspection Date: 2019-06-26
- Product Type: drugs
- Office Name: Division of Northeast Imports 
- Summary: An FDA inspection of American International Chemical, LLC in Framingham, MA, in June 2019, revealed inadequate quality oversight concerning drug products. The firm distributed out-of-specification Urea, USP, and failed to conduct a thorough investigation into the product quality and potential impact of the impurity. This indicates a significant lapse in quality control for distributed drug products.

## Related Officers

- [Investigator](https://www.keypedia.com/people/erik-w-koester/2bbab081-6783-40a1-83c1-b219bde22bd1)
- [Robert J. Martin](https://www.keypedia.com/people/robert-j-martin/8bd5c75a-ec53-4ae5-9739-a39489686cae)

Company: https://www.keypedia.com/companies/lbb-specialties-holdings-llc/2960d723-d60c-4a5c-a632-fc05fd323ebe

Office: https://www.keypedia.com/offices/division-of-northeast-imports/b20599cf-9797-41fd-947f-6589ef596a94