Warning Letter — Bausch & Lomb Inc.
The FDA Center for Drug Evaluation and Research (CDER) issued a Warning Letter to Bausch & Lomb Inc. following an evaluation of company operations.
This affects Bausch & Lomb Inc. and its internal departments responsible for regulatory compliance, quality management, and pharmaceutical manufacturing oversight.
The issuance of a CDER Warning Letter indicates that the FDA identified significant violations of regulatory requirements during its review. This may lead to restricted product distribution or delayed approvals for new applications until the identified deficiencies are remediated to the agency's satisfaction.
QA and Compliance teams should conduct a thorough review of manufacturing site protocols and ensure that internal audit findings are addressed with robust corrective actions. Regulatory departments should prepare for potential follow-up inspections to verify adherence to standards referenced in the warning letter.
FDA Warning Letter issued to: Bausch & Lomb Inc.. 09/04/2026 — Center for Drug Evaluation and Research (CDER). Source: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/bausch-lomb-inc-732398-09042026
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