# FDA 483 - Carrollclean, LLC - August 31, 2023

Source: https://www.globalkeysolutions.net/records/483/carrollclean-llc/951ea2a0-1b04-4ccb-b6ad-8309ed5300d5

> FDA 483 for Carrollclean, LLC on August 31, 2023. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Carrollclean, LLC
- Inspection Date: 2023-08-31
- Product Type: drugs
- Office Name: Division of Human and Animal Food Operations - West III
- Summary: An FDA inspection of Carrollclean, LLC in Garland, TX, a manufacturer of Antimicrobial Hand Soap, revealed significant deficiencies in their quality system. Observations included failure to follow written production and process control procedures, leading to the release of out-of-specification product without proper justification. Additionally, the firm used uncalibrated test equipment, specifically a viscometer, to approve product for release.

## Related Officers

- [investigator](https://www.globalkeysolutions.net/people/kevin-t-nguyen/5ae9d562-7e4f-4305-895a-4b39c35acd16)

Company: https://www.globalkeysolutions.net/companies/carrollclean-llc/94e26de7-fef7-415e-bee4-dc911dc0b0db

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