# FDA 483 - AMCOL Health & Beauty Solutions, Inc DBA AMCOL Household and Personal Care - April 25, 2025

Source: https://www.globalkeysolutions.net/records/483/amcol-health-beauty-solutions-inc-dba-amcol-household-and-personal-care/611c6912-8aea-49a9-bbf8-1b1af6c9c602

> FDA 483 for AMCOL Health & Beauty Solutions, Inc DBA AMCOL Household and Personal Care on April 25, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: AMCOL Health & Beauty Solutions, Inc DBA AMCOL Household and Personal Care
- Inspection Date: 2025-04-25
- Product Type: drugs
- Office Name: New Orleans District Office
- Summary: AMCOL Health and Beauty Solutions Care, a drug manufacturer in Lafayette, LA, was inspected by the FDA. The inspection revealed significant issues including inadequate investigations into out-of-specification results and customer complaints for OTC drug products, as well as a failure to properly test and release drug product containers before use. These findings indicate deficiencies in quality control and manufacturing processes.

## Related Documents

- [EIR - 2018-12-06](https://www.globalkeysolutions.net/records/eir/amcol-health-beauty-solutions-inc-dba-amcol-household-and-personal-care/b2e481b7-be73-435c-89c9-1470f10987d5)
- [483 - 2018-12-04](https://www.globalkeysolutions.net/records/483/amcol-health-beauty-solutions-inc-dba-amcol-household-and-personal-care/84487361-ea7d-48f9-8c67-cf19566ff45b)

## Related Officers

- [Medical Officer at FDA](https://www.globalkeysolutions.net/people/brittny-c-cargo/a3479241-5390-4ddb-b892-df0bac1c89cf)

Company: https://www.globalkeysolutions.net/companies/amcol-health-beauty-solutions-inc-dba-amcol-household-and-personal-care/8e6cd831-d279-4916-bf97-b3f3713a5250

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