FDA 483 - Tenco Assemblies, Inc. - November 14, 2025

Tenco Assemblies, Inc., a repackager and relabeler based in Morrisville, PA, was subject to an FDA inspection from November 12 to 14, 2025. The U.S. Food and Drug Administration issued one observation on Form FDA 483, indicating a lapse in quality control documentation and procedures.

The main issue identified was the failure to properly document the examination results of packaged and labeled products within batch production and control records. Specifically, production staff were observed using an undocumented secondary scale to re-weigh cartons that had been rejected by a primary checkweigher. Products passing this secondary inspection were then released. The company’s Quality Assurance Manager confirmed there was no established written procedure for using this secondary scale, nor was its use documented in the batch records.

This observation points to a deviation from established regulatory expectations for maintaining comprehensive records and validated procedures in product manufacturing and release. To address this, Tenco Assemblies, Inc. is required to develop and implement corrective actions. These actions should include establishing clear, documented procedures for all critical quality processes, particularly those involving product evaluation and release, and ensuring all such activities are thoroughly recorded in batch documentation to ensure regulatory compliance and product quality.