# FDA 483 - Long Grove Pharmaceuticals LLC - November 06, 2024

Source: https://www.globalkeysolutions.net/records/483/long-grove-pharmaceuticals-llc/b3f64c36-e62e-4432-94e6-f1cf0304baf2

> FDA 483 for Long Grove Pharmaceuticals LLC on November 06, 2024. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Long Grove Pharmaceuticals LLC
- Inspection Date: 2024-11-06
- Product Type: drugs
- Office Name: Chicago District Office
- Summary: Long Grove Pharmaceuticals, LLC, an application holder and distributor for drug products, was cited for significant deficiencies during an FDA inspection. The firm lacks a functional quality control unit, written procedures for quality unit responsibilities, and failed to adequately investigate a complaint regarding potential bacterial contamination in a distributed drug product. These observations indicate serious non-compliance with regulatory requirements.

## Related Officers

- [Michele L. Glendenning](https://www.globalkeysolutions.net/people/michele-l-glendenning/a3c23a43-634c-4140-807b-c17fbc03bb00)
- [Angela C. Welker](https://www.globalkeysolutions.net/people/angela-c-welker/b732b19f-c8e8-43b0-bc81-8dcde8a53c84)

Company: https://www.globalkeysolutions.net/companies/long-grove-pharmaceuticals-llc/efe5576b-de03-4c98-ad6c-6cda45364d63

Office: https://www.globalkeysolutions.net/offices/chicago-district-office/a510300b-0eaf-4a33-90b5-231d95977669