# FDA 483 - Armand Products Company - October 01, 2019

Source: https://www.globalkeysolutions.net/records/483/armand-products-company/add85a1b-e030-4f82-8ae6-e36e0819293f

> FDA 483 for Armand Products Company on October 01, 2019. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Armand Products Company
- Inspection Date: 2019-10-01
- Product Type: drugs
- Office Name: New Orleans District Office
- Summary: Armand Products Company, Inc. in Muscle Shoals, AL, a drug component manufacturer, was cited for significant contamination issues during the production of potassium bicarbonate, USP. The firm's manufacturing system is known to leach contaminants and shed metal pieces, a problem they have been aware of since at least September 2017 without implementing corrective actions. Despite frequent detection of metal during packaging, contaminated batches were released as USP grade material.

## Related Officers

- [ Drug Investigator](https://www.globalkeysolutions.net/people/samantha-j-bradley/ba45f64f-07a9-4933-833f-b9b339c57783)

Company: https://www.globalkeysolutions.net/companies/armand-products-company/dd6bea59-47f9-4fc6-8b97-1a940a261636

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