# FDA 483 - Liposales LLC - August 05, 2021

Source: https://www.globalkeysolutions.net/records/483/liposales-llc/03447b3f-f90c-47da-926e-3e2c2482ca81

> FDA 483 for Liposales LLC on August 05, 2021. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Liposales LLC
- Inspection Date: 2021-08-05
- Product Type: device
- Office Name: Division of Human and Animal Food Operations - West III
- Summary: An FDA inspection of Lipozales LLC in Houston, TX, a relabeler/repackager, identified five significant observations related to a lack of established written procedures. The firm failed to implement procedures for critical quality system elements including labeling control, product handling, complaint management, design output documentation, and acceptance activities. These deficiencies indicate a systemic failure to ensure product quality and compliance with regulatory requirements.

## Related Officers

- [Ellen J. Tave](https://www.globalkeysolutions.net/people/ellen-j-tave/a70cd3ed-957f-471b-82ff-24ca7c65bc10)

Company: https://www.globalkeysolutions.net/companies/liposales-llc/70720286-6bdc-4d70-ad12-a11b7ac82b43

Office: https://www.globalkeysolutions.net/offices/division-of-human-and-animal-food-operations-west-iii/2cda09a5-06c4-433f-9df0-0d7903a6efab