Warning Letter — Laboratorios Dr. Collado S.A.
The FDA issued a Warning Letter to Laboratorios Dr. Collado S.A. following an evaluation by the Center for Drug Evaluation and Research (CDER).
This affects Laboratorios Dr. Collado S.A., their supply chain partners, and regulatory compliance departments overseeing drug manufacturing operations.
A Warning Letter from CDER typically indicates significant deviations from Current Good Manufacturing Practice (CGMP). This may result in the FDA withholding approval of new applications or supplements, and could lead to the entry of products into the United States being refused. The source indicates a formal escalatory action following an inspection or review.
Facilities should immediately review current manufacturing practices against CGMP standards and prepare for potential importation restrictions if compliance gaps exist. Quality teams should conduct internal audits focusing on documentation and process controls prior to any subsequent FDA interactions.
FDA Warning Letter issued to: Laboratorios Dr. Collado S.A.. 06/02/2026 — Center for Drug Evaluation and Research (CDER). Source: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/laboratorios-dr-collado-sa-723285-06022026
Open in openFDA / FDA.gov