Warning Letter — Woodbine Products Company Inc.
The FDA issued a Warning Letter to Woodbine Products Company Inc. following a Center for Drug Evaluation and Research (CDER) review of the facility's compliance status.
This affects Woodbine Products Company Inc., specifically their quality and manufacturing leadership, as well as regulatory professionals responsible for CDER-regulated products.
A Warning Letter from CDER indicates significant deviations from Current Good Manufacturing Practice (CGMP) or other regulatory requirements. Failure to address the underlying issues may lead to further enforcement actions, such as seizure of products, injunctions, or withholding of drug approvals. The issuance suggests that previous responses to inspectional observations may have been deemed inadequate by the agency.
QA and Regulatory teams should review current CGMP compliance protocols, verify that all manufacturing processes align with CDER standards, and ensure that any previously identified inspectional observations have been fully remediated and documented.
FDA Warning Letter issued to: Woodbine Products Company Inc.. 07/27/2026 — Center for Drug Evaluation and Research (CDER). Source: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/woodbine-products-company-inc-729345-07272026
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