Warning Letter — Laboratorios Jaloma S.A. de C.V.
The FDA issued a Warning Letter to Laboratorios Jaloma S.A. de C.V. following a review of facility operations by the Center for Drug Evaluation and Research (CDER). The letter identifies significant deviations from current good manufacturing practice (CGMP) for finished pharmaceuticals.
This action primarily affects Laboratorios Jaloma S.A. de C.V., specifically their manufacturing operations, quality management systems, and personnel responsible for drug production compliance.
This enforcement action signifies that the FDA has identified systemic failures in the firm's ability to maintain CGMP compliance. This may lead to import alerts or the withholding of drug approvals until the violations are remediated. The issuance of a Warning Letter by CDER suggests that previous responses or inspections failed to adequately address the agency's concerns regarding product quality or manufacturing integrity.
Regulatory and QA teams should ensure that all manufacturing facilities, including international sites, maintain strict adherence to CGMP standards. Firms should conduct comprehensive internal audits of production processes and documentation to identify and rectify potential compliance gaps before FDA inspection.
FDA Warning Letter issued to: Laboratorios Jaloma S.A. de C.V.. 05/22/2026 — Center for Drug Evaluation and Research (CDER). Source: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/laboratorios-jaloma-sa-de-cv-725939-05222026
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