Entrusted Manufacturing Oversight Tightens: Two Medical Device Companies Named in Flight Inspection

Quality System in Name Only

In this inspection, the registrant's quality system issues were particularly prominent. The company only had its legal representative concurrently serving as the enterprise head, without appointing a management representative or assigning technical, production, and quality leaders. As a result, the quality system lacked the necessary organizational support.

At the same time, the entrusted manufacturer had missing training records for personnel in certain positions, reflecting clear gaps in on-site personnel management.

Regulators considered these findings inconsistent with the requirements of the Medical Device Good Manufacturing Practice for establishing and effectively operating a quality management system.

Entrusted Manufacturing Management Failed

In entrusted manufacturing management, both the registrant and the entrusted manufacturer exposed serious control failures. The registrant's quality system documents did not cover the current entrusted manufacturing activities, supplier audit and evaluation records could not be provided, and product sales records were missing.

Even after learning that a product had failed sampling inspection, the registrant still did not submit a recall report as required.

More seriously, the inspection found doubts over the authenticity of the management representative's signature, suggesting that the release review mechanism had become a formality.

This case again shows that entrusted manufacturing does not mean outsourcing responsibility. The registrant must still bear primary responsibility for product quality and safety throughout the full product lifecycle.

Production Records Were Unreliable

The entrusted manufacturer's issues were concentrated in production and quality control. The flight inspection found that production was not carried out at the address approved in the medical device production license, indicating off-site production.

Batch production records and material management records could not be matched, which undermined product traceability. In addition, the company had not established incoming material inspection procedures, several batches lacked inspection records, and products manufactured at an unapproved site were still released.

Regulators considered that these issues had seriously affected the authenticity and controllability of product quality.

From an industry perspective, such issues are not only procedural defects. They may directly affect product safety and effectiveness.

For medical device companies, relying only on an entrusted manufacturing agreement is no longer sufficient. Registrants need to establish end-to-end quality control covering supplier management, production supervision, release review, adverse event handling, and recall management. Otherwise, they are likely to become priority targets in flight inspections.