Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) has officially begun publishing GMP Inspection Non-Compliance Notices, marking a significant shift in its regulatory approach. This new policy is designed to enhance transparency within the pharmaceutical industry and serve as a preventative tool. By publicly detailing severe Good Manufacturing Practice (GMP) violations and the reasons for failing inspections, the PMDA aims to share critical “lessons learned” with the broader industry, encouraging proactive compliance and preventing the recurrence of systemic quality failures across other manufacturers.
■ Differences Between PMDA Non-Compliance Notices and U.S. FDA Warning Letters
FDA Warning Letters and PMDA GMP inspection publications serve distinct regulatory functions. An FDA Warning Letter is a direct notification sent to a company to identify significant violations, such as poor manufacturing practices, requiring a time-bound response to outline corrective actions or provide reasoning for disagreement. Conversely, the PMDA’s initiative is a program to publish GMP inspection statuses (pass/fail) on its website to improve transparency of PMDA’s supervision. The most critical difference is that the PMDA will only publish a “non-compliant” result if the inspected manufacturer provides explicit prior consent, unless the failure has already been reported by the media.
■ Details of the Inaugural Non-Compliance Notice
The first publicly released GMP Inspection Non-Compliance Notice was issued by the Wakayama Prefectural Governor to Kasano Kosan Co., Ltd. on September 1, 2026, following on-site inspections conducted in February 2026. The document reveals critical and systemic failures rooted in deliberate falsification and the total collapse of the facility’s pharmaceutical quality system.
The notice outlines three primary categories of severe violations:
1. Fabrication of Stability Monitoring Data:
The facility systematically mishandled Out-of-Specification (OOS) results during stability monitoring for multiple products. Under the direction of the Manufacturing Supervisor, the company failed to conduct mandatory testing, fabricated passing numerical values, and neglected to investigate the root causes of OOS results. When a product failed testing, the Manufacturing Supervisor instructed staff to test retention samples instead and fraudulently reported these passing results to the marketing authorization holder. Executives were aware of these deceptive practices by at least August 2021 but failed to take corrective action.
2. Process Control Deviations and Record Falsification:
For a specific product identified as “Drug A”, out-of-spec viscosity results were routinely recorded but ignored. The Manufacturing Supervisor instructed staff not to create deviation records and, in some batches, directly falsified the manufacturing records by entering in-spec viscosity values. Consequently, personnel improperly authorized the release of non-compliant batches into the market.
3. Paralysis of the Quality Assurance System
The deliberate misconduct led by the Manufacturing Supervisor completely incapacitated the Quality Assurance (QA) department, preventing them from ensuring manufacturing procedures aligned with approved standards. The facility fell into a chronic state where evaluating the impact of deviations on product quality was impossible.
Consequently, the regulatory authority issued a “Non-Compliant” judgment because Kasano Kosan Co., Ltd. failed to provide acceptable, finalized corrective actions within 15 business days after receiving the initial observation report.
Author
GMP Platform Consultant, CM Plus Corporation
After Lily graduated from Shenyang Pharmaceutical University in 2005, she entered in a big Japanese engineering company. As a validation engineer of GMP Department, Lily took part in Japanese Pharmaceutical companies’ new factories construction project and worked on validation and DQ/IQ/OQ documentation. In 2010, Lily joined in Shanghai Tofflon Science and Technology Co., Ltd. and worked as International Affairs Director to coordinate the cooperation with Japanese companies.
Lily has taken part in PMDA’S GMP inspection to Chinese API plant as an interpreter for several times. Lily can speak Chinese, Japanese and English, and now she is responsible for providing support for Chinese regulatory matters, assists with market entry into China, and handles domestic and international GMP audits as well as interpretation services.
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