# FDA 483 - Water-Jel Technologies, LLC - September 20, 2024

Source: https://www.keypedia.com/records/483/water-jel-technologies-llc/7b34f25e-555e-47ad-9444-ecd5b2a559da

> FDA 483 for Water-Jel Technologies, LLC on September 20, 2024. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Water-Jel Technologies, LLC
- Inspection Date: 2024-09-20
- Product Type: drugs
- Office Name: Atlanta District Office
- Summary: Water-Jel Technologies, LLC in Huntersville, NC, was inspected and received a Form 483 with two observations. The firm failed to thoroughly review unexplained discrepancies and complete stability OOS and non-conformance investigations in a timely manner. Additionally, the written stability testing program was not followed, specifically regarding the establishment of drug product stability protocols.

## Related Officers

- [Susan O. Oladeji](https://www.keypedia.com/people/susan-o-oladeji/307277f8-7704-4ada-8d8d-d77118c6cb77)

Company: https://www.keypedia.com/companies/water-jel-technologies-llc/70ca8046-5140-4a07-a284-c14ea4d187e8

Office: https://www.keypedia.com/offices/atlanta-district-office/7586d99a-288e-49d1-8c3d-d88b7354b7a7