# FDA 483 - Formulated Solutions Cleveland LLC - April 12, 2024

Source: https://www.keypedia.com/records/483/formulated-solutions-cleveland-llc/87ac3ddd-6f4c-4a8c-a5e4-b21e7c488030

> FDA 483 for Formulated Solutions Cleveland LLC on April 12, 2024. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Formulated Solutions Cleveland LLC
- Inspection Date: 2024-04-12
- Product Type: drugs
- Office Name: New Orleans District Office
- Summary: Formulated Solutions Cleveland, LLC, an OTC drug manufacturer, received a Form FDA 483 following an inspection from April 8-12, 2024. The inspection identified one observation related to inadequate laboratory controls. Specifically, the firm failed to establish scientifically sound specifications and perform testing to ensure technical grade alcohol used as an ingredient in drug products met USP standards.

## Related Officers

- [Gretchen M. Laws](https://www.keypedia.com/people/gretchen-m-laws/9a3ecebd-099b-41d5-a2a7-70811a26cae1)

Company: https://www.keypedia.com/companies/formulated-solutions-cleveland-llc/1c389813-c280-4816-a187-91b0ec4b6d84

Office: https://www.keypedia.com/offices/new-orleans-district-office/95352142-b992-4e06-849d-d7483c0959ea