Warning Letter — Bentley Laboratories LLC
The FDA issued a Warning Letter to Bentley Laboratories LLC following an inspection by the Center for Drug Evaluation and Research (CDER) that identified violations of Current Good Manufacturing Practice (CGMP) regulations.
This affects Bentley Laboratories LLC, its contract manufacturing clients, and personnel responsible for drug manufacturing, quality control, and regulatory compliance.
The issuance of a Warning Letter by CDER indicates that the facility's quality systems may not sufficiently ensure the safety, identity, strength, quality, or purity of the products manufactured. Failure to remediate these issues could lead to further enforcement actions, such as seizure of products, injunctions, or withholding of drug approvals.
Conduct a comprehensive audit of current manufacturing processes against CGMP standards, ensuring all deviations are documented and investigated. Review quality systems to verify that all laboratory testing and production controls meet CDER requirements for finished drug products.
FDA Warning Letter issued to: Bentley Laboratories LLC. 09/17/2026 — Center for Drug Evaluation and Research (CDER). Source: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/bentley-laboratories-llc-732028-09172026
Open in openFDA / FDA.gov