# FDA 483 - Leading Edge Innovations, LLC - November 04, 2025

Source: https://www.keypedia.com/records/483/leading-edge-innovations-llc/feeecbad-bc5c-45cd-9032-8dd8bba4e544

> FDA 483 for Leading Edge Innovations, LLC on November 04, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Leading Edge Innovations, LLC
- Inspection Date: 2025-11-04
- Product Type: drugs
- Office Name: New Jersey District Office
- Summary: Leading Edge Innovations, LLC, a drug manufacturer in Branchburg, NJ, was inspected by the FDA and received a Form 483 with nine observations. The inspection revealed significant deficiencies across various aspects of drug manufacturing, including inadequate process validation, unqualified equipment, insufficient stability data, lack of raw material testing, poor cleaning validation and insanitary conditions, unsuitable facility construction, improper storage conditions, incomplete master production records, and a failure to conduct annual product reviews. These issues indicate a broad lack of adherence to cGMP requirements, posing potential risks to drug product quality, identity, strength, and purity.

## Related Officers

- [investigator](https://www.keypedia.com/people/anthony-j-donato/a6dd6e14-529e-4b23-9b5f-02c88afb80ae)
- [Drug Investigator](https://www.keypedia.com/people/jessica-s-estriplet/b7152ec3-6e1b-45aa-840e-7147f357aea2)

Company: https://www.keypedia.com/companies/leading-edge-innovations-llc/b707a38f-d955-4777-9c37-9b46e2100962

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