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What types of deficiency might the Department of Health issue after an inspection, and how should you respond?

A complete explanation of the regulatory basis, Drew Tang’s recommendations and risk alerts. The original material dates from 2025; read it alongside the latest official requirements.

Original guide, 2025 edition: These FAQs are provided for topic-based reference and have not all been individually checked against current rules. Please confirm fees, personnel, renewal, changes and product requirements against the professional in-depth guide for the relevant licence type and the official requirements in force at the time.

Drug Office, Department of Health Chinese Medicines Board

Q192 · Category D: Premises and Storage Requirements (Q151-Q200)
After the site inspection, the Department of Health’s inspection report will usually classify findings (deficiencies) into three levels, in ascending order of severity: 1. **Other**: The least serious level, usually covering observations or recommendations that do not directly breach GDP but indicate room for improvement. 2. **Major**: A deficiency involving failure to comply with GDP principles that may result in medicines not being handled in accordance with their approved conditions, or pose a potential risk to patients, but is not life-threatening. Examples include missing temperature and humidity records for some periods, or incomplete cleaning records. 3. **Critical**: The most serious level, referring to a deficiency that may threaten patients’ lives or cause serious harm to health, or involve fraud, falsification or similar conduct. Examples include finding expired medicines in the released goods area, a complete break in the cold chain, or falsified records. The response should be as follows: on receipt of the report, you must submit a written corrective and preventive action plan (CAPA Plan) within the specified period (usually 1–2 weeks), explaining in detail how you will correct the deficiencies identified and what measures you will take to prevent them from recurring.

📘 Regulatory basis

The classification and handling procedures for deficiencies are based on internationally accepted pharmaceutical regulatory principles, such as the guidance of the Pharmaceutical Inspection Co-operation Scheme (PIC/S). The Department of Health’s inspection and assessment standards are consistent with these international standards.

📗 Drew Tang's recommendations

Treat any deficiencies identified seriously and constructively. The key to writing a CAPA report is “Root Cause Analysis”; do not stop at the surface-level problem. For example, if expired medicines are found, the root cause may not be staff carelessness but the lack of an expiry alert function in the WMS. A thorough CAPA report can demonstrate your management commitment and capability to the Department of Health. Rengangyongsheng (Hong Kong) Limited has extensive experience assisting clients in responding to inspection deficiencies.

📕 Risk notice

A “critical” deficiency will almost certainly result in your licence application being refused or your existing licence being suspended until you complete remediation and pass a follow-up inspection. Several “major” deficiencies may also accumulate to produce the same result. Ignoring an inspection report or responding to it perfunctorily will be regarded as contempt for the regulator and may lead to more serious consequences.

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