# FDA 483 - LSNE Madison LLC - October 16, 2025

Source: https://www.keypedia.com/records/483/lsne-madison-llc/81553ec9-bc52-4738-8da6-806639ed48eb

> FDA 483 for LSNE Madison LLC on October 16, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: LSNE Madison LLC
- Inspection Date: 2025-10-16
- Product Type: drugs
- Office Name: Minneapolis District Office
- Summary: An FDA inspection, with observations noted on October 8 and 14, 2025, identified significant deficiencies at an unnamed pharmaceutical firm regarding aseptic processing and adherence to standard operating procedures (SOPs). The inspection revealed an inadequate system for cleaning and disinfecting aseptic processing areas. Specifically, the firm failed to adequately validate its cleaning and disinfecting processes for sterile operations, with issues such as insufficient mop reach and width under the Restricted Access Barrier System (RABS) filling unit, and the relevant SOP lacking detailed instructions for cleaning this critical area. Furthermore, the firm consistently failed to follow its established SOPs for ISO Room Cleaning and Aseptic Technique. Deviations observed during cleaning activities included operators not maintaining slow, deliberate movements, fidgeting, improper use of cleaning equipment (e.g., rolling tables over wet floors, walking through wet areas), placing items on wet surfaces, ineffective mop wringing, and leaving debris. During filling operations, similar issues persisted, with operators failing to adhere to aseptic techniques, congregating, and omitting required sanitization steps. These findings indicate non-compliance with current Good Manufacturing Practices (cGMP) for aseptic manufacturing. The firm is required to address these observations promptly by implementing comprehensive corrective and preventive actions and submitting them to the FDA for review.

## Related Documents

- [483 - 2024-10-11](https://www.keypedia.com/records/483/lsne-madison-llc/96855540-ce5b-45e8-b1a0-a26cfcf88f94)
- [483 - 2025-10-16](https://www.keypedia.com/records/483/lsne-madison-llc/fe46f962-077c-4a53-8293-3351f47df7ff)

## Related Officers

- [Lori B. Wilkstrom](https://www.keypedia.com/people/lori-b-wilkstrom/541f4a17-d0d3-4a8e-a105-13f18c8bc4c4)

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

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