# FDA 483 - Clean Solutions LLC - May 10, 2024

Source: https://www.globalkeysolutions.net/records/483/clean-solutions-llc/bad4c8f8-5594-4280-be6e-005fc3b846c5

> FDA 483 for Clean Solutions LLC on May 10, 2024. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Clean Solutions LLC
- Inspection Date: 2024-05-10
- Product Type: drugs
- Office Name: New Jersey District Office
- Summary: Clean Solutions LLC, an OTC manufacturer in Clifton, NJ, was inspected by the FDA from May 6-10, 2024. The inspection revealed significant deficiencies across multiple areas of its manufacturing operations, including a complete lack of quality control, inadequate testing of raw materials and finished products, and unvalidated processes and equipment. These serious violations indicate a systemic failure to adhere to CGMP requirements for the production of Antibacterial Hand Soap.

## Related Documents

- [WARNING_LETTER - 2024-05-10](https://www.globalkeysolutions.net/records/warning_letter/clean-solutions-llc/c3056c09-b32d-44e8-84de-63d3f00fe971)

## Related Officers

- [Olumide A Akinyosoye](https://www.globalkeysolutions.net/people/olumide-a-akinyosoye/6ae07a21-bad4-442d-b73b-9619f2d9febc)
- [issuing_officer](https://www.globalkeysolutions.net/people/catherine-o-lamptey/9ddfa564-70b7-4a8b-9209-9d21205ebf60)
- [Vivin George](https://www.globalkeysolutions.net/people/vivin-george/0b0ee298-a577-4bee-b18e-42da0c3bb148)

Company: https://www.globalkeysolutions.net/companies/clean-solutions-llc/12cf9555-d811-4727-bf49-5415016c61a1

Office: https://www.globalkeysolutions.net/offices/new-jersey-district-office/6ff5e2e9-5cff-44c7-af24-5a55329a8248