Sanofi gets FDA warning letter for Genzyme plant, supply chain remains unaffected

The FDA has issued a warning letter to Sanofi’s Genzyme facility in Framingham, Massachusetts, citing multiple manufacturing violations. Despite the regulatory scrutiny, Sanofi confirmed that there has been no disruption to the supply of drugs from the plant.

The warning letter, posted by the FDA on Tuesday, follows an inspection conducted between June 12 and July 9, 2024. The agency flagged issues including substandard investigations into manufacturing errors, microbiological contamination, and improper equipment use. It also criticized the facility for inconsistent active pharmaceutical ingredient (API) production and inadequate quality control measures.

Sanofi, which acquired Genzyme in 2011, responded to the findings, stating it is “fully committed to resolving all issues holistically and promptly.” A company spokesperson emphasized that manufacturing operations and drug supplies remain uninterrupted, even as Sanofi works to align with FDA requirements.

The Framingham site plays a key role in Sanofi’s operations, particularly in producing therapies for rare diseases and other critical areas.