# FDA 483 - Northwind Pharmaceuticals LLC - September 26, 2025

Source: https://www.keypedia.com/records/483/northwind-pharmaceuticals-llc/84d94d17-29f2-4ad9-ac88-d231714af0fc

> FDA 483 for Northwind Pharmaceuticals LLC on September 26, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Northwind Pharmaceuticals LLC
- Inspection Date: 2025-09-26
- Product Type: drugs
- Office Name: Detroit District Office
- Summary: Northwind Pharmaceuticals LLC, a repacker and distributor in Indianapolis, IN, was cited for significant deficiencies in its quality control unit during an FDA inspection. The firm failed to adequately follow established procedures, leading to issues with cleaning verification, documentation of packaging activities, temperature monitoring, and product quarantine. These findings indicate a lack of adherence to quality control responsibilities and procedures.

## Related Officers

- [FDA_PERSONNEL](https://www.keypedia.com/people/aranjeet-singh/7359f43e-0e36-4cdd-a77d-3371d8b44b99)

Company: https://www.keypedia.com/companies/northwind-pharmaceuticals-llc/7f3f6efe-3163-4fcb-8af9-125c1bad3a40

Office: https://www.keypedia.com/offices/detroit-district-office/b09a1815-a000-40c0-bb44-5432ce87ed03