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# Lonza Walkersville, MD Facility Slapped with Warning Letter
- URL: https://www.fdaweb.com/lonza-walkersville-md-facility-slapped-with-warning-letter/
- Published: 2017-04-25T12:00:00.000Z
- Updated: 2026-09-14T22:19:37.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5138534

In announcing a record first quarter, Lonza says it was issued an FDA Warning Letter 4/24 after an inspection at the firm’s Walkersville, MD “bioscience solutions” manufacturing plant. The letter raised concerns with validation and the company’s aseptic operations — issues the company says it is currently addressing.

The company says manufacturing in the troubled area was suspended while it takes corrective actions. It expects to resume production later this year.

  
The “for cause” inspection was based on a customer complaint involving Lonza’s “For Further Manufacturing” media that is used by several other companies in their manufacturing. The company says it confirmed a “sterility issue” and opened an internal investigation before FDA arrived at the site.