# FDA 483 - LSNE Madison LLC - October 11, 2024

Source: https://www.globalkeysolutions.net/records/483/lsne-madison-llc/96855540-ce5b-45e8-b1a0-a26cfcf88f94

> FDA 483 for LSNE Madison LLC on October 11, 2024. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: LSNE Madison LLC
- Inspection Date: 2024-10-11
- Product Type: drugs
- Office Name: Minneapolis District Office
- Summary: The FDA inspection of Lyophilization Services of New England (LSNE) (Doing Business As PCI) in Madison, WI, revealed significant deficiencies in aseptic processing, environmental monitoring, and contamination control for sterile drug products. The firm failed to establish and follow adequate procedures to prevent microbial contamination, maintain equipment, and ensure product quality. These issues indicate a high severity of non-compliance across multiple critical manufacturing areas.

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## Related Officers

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Company: https://www.globalkeysolutions.net/companies/lsne-madison-llc/97b52716-6508-4868-9609-761c6bc02db4

Office: https://www.globalkeysolutions.net/offices/minneapolis-district-office/c79fc8dc-f884-48fc-ba80-2947f662511d