# FDA 483 - Alkaline Corp. - September 06, 2024

Source: https://www.keypedia.com/records/483/alkaline-corp/05440fa8-dbde-41ad-9d5a-7fd8269a59c3

> FDA 483 for Alkaline Corp. on September 06, 2024. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Alkaline Corp.
- Inspection Date: 2024-09-06
- Product Type: drugs
- Office Name: New Jersey District Office
- Summary: Alkaline Corp. in Eatontown, NJ, was inspected regarding its manufacturing of drug products, specifically hand sanitizers. The inspection revealed significant deficiencies across its quality system, including the absence of a quality control unit, inadequate component testing, lack of stability data, and incomplete batch records. These issues indicate a severe lack of adherence to Good Manufacturing Practices.

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## Related Officers

- [Advisor](https://www.keypedia.com/people/frederick-razzaghi/7346f6ec-1d9a-4ad3-abde-0497dcd9c8b5)

Company: https://www.keypedia.com/companies/alkaline-corp/6ef105b8-4b98-4cdd-b815-dcce28800781

Office: https://www.keypedia.com/offices/new-jersey-district-office/6ff5e2e9-5cff-44c7-af24-5a55329a8248