Warning Letter — AF Import & Wholesale Co
The FDA issued a Warning Letter to AF Import & Wholesale Co. following an evaluation by the Office of Inspections and Investigations.
This action affects AF Import & Wholesale Co., as well as logistics, compliance, and quality departments involved in the import and wholesale distribution of FDA-regulated products.
The issuance of a Warning Letter by the Office of Inspections and Investigations indicates documented significant violations of FDA regulations. For wholesale and import entities, this typically suggests failures in supplier qualification, product labeling, or the importation of unapproved/misbranded goods. This may result in increased scrutiny of future shipments and potential import alerts if the underlying compliance issues are not remediated.
Regulatory and QA teams should conduct an immediate audit of import documentation and supplier verification records. Firms should ensure that all imported products meet specific FDA monograph or pre-market requirements before distribution to avoid enforcement actions under the Office of Inspections and Investigations.
FDA Warning Letter issued to: AF Import & Wholesale Co. 05/26/2026 — Office of Inspections and Investigations. Source: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/af-import-wholesale-co-730187-05262026
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