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

Source: https://www.keypedia.com/records/483/alkaline-corp/176d4c13-76ff-4d55-9fb6-4d6979c25477

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

---

## Details

- Record Type: 483
- Company Name: Alkaline Corp.
- Inspection Date: 2024-09-06
- Product Type: drugs
- Office Name: Food and Drug Administration
- Summary: An FDA inspection of Alkaline Corp. from February 15 to September 6, 2024, revealed significant deficiencies in their manufacturing operations for drug products. The primary issues identified involved a lack of a functional quality control unit responsible for reviewing and approving critical production documents and processes. Key violations included insufficient qualification of raw material suppliers, specifically for Glycerin and Ethanol, where component reliability was not adequately established through testing or proper certification. The company also lacked a written program and supporting data to assess drug product stability, failing to validate the shelf life of their hand sanitizers. Furthermore, batch production records were incomplete, omitting details such as significant manufacturing steps, dates, equipment used, and investigation results. There was no adequate incoming quality inspection for packaging and labeling materials, and critical equipment cleaning procedures were not formally established or verified for effectiveness. Critically, the identity of components like Glycerin was not fully verified, with no testing for hazardous impurities such as Diethylene Glycol and Ethylene Glycol. These observations indicate a failure to adhere to Current Good Manufacturing Practices (cGMP) for drug products. Alkaline Corp. is required to provide a comprehensive response detailing corrective and preventive actions to address each identified deficiency.

## Related Documents

- [483 - 2022-08-16](https://www.keypedia.com/records/483/alkaline-corp/295e9998-6e0e-448f-bf6a-ea93e63c1dae)
- [483 - 2024-09-06](https://www.keypedia.com/records/483/alkaline-corp/05440fa8-dbde-41ad-9d5a-7fd8269a59c3)

## Related Officers

- [Mr. Aron Shapiro](https://www.keypedia.com/people/mr-aron-shapiro/4e7e6c39-4aa7-4cdc-8a62-620b3479374c)
- [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/food-and-drug-administration/437fdb2a-5048-42aa-aaea-ea28efe65516