CDAKB Inspections
Overview
Kemenkes conducts Good Distribution Practice inspections (CDAKB inspections) of all Indonesian medical device distributors and LAR entities that hold IDAK licences. These inspections verify ongoing compliance with the CDAKB requirements for storage, traceability, complaint handling, and recall readiness.
Types of Inspections
| Type | Description |
|---|---|
| Initial certification inspection | Required before the first CDAKB certificate is issued; must pass before first NIE can be registered |
| Periodic re-inspection | Routine inspection to verify continued compliance; frequency depends on risk profile and compliance history |
| Unannounced inspection | Triggered by adverse events, complaints, FSCA non-compliance, or risk-based surveillance decisions |
| Follow-up inspection | Conducted after corrective actions were required in a previous inspection |
What Is Assessed in a CDAKB Inspection
Kemenkes inspectors assess all elements of the CDAKB framework:
| Area | Key Assessment Points |
|---|---|
| Quality Management System | Documentation, SOPs, management review, internal audits |
| Personnel | Responsible person qualifications, training records, competence |
| Premises and facilities | Warehouse condition, temperature/humidity monitoring, segregation of products (quarantine, approved, rejected) |
| Equipment | Calibration records for temperature monitoring equipment |
| Incoming goods | Receipt procedure, inspection on arrival, documentation |
| Storage | FIFO/FEFO compliance, segregation, pest control |
| Dispatch and distribution | Delivery records, customer qualification, cold chain (if applicable) |
| Traceability | Ability to trace specific lot numbers to customers |
| Complaints | Complaint log, investigation process, CAPA |
| Returns | Segregation and evaluation of returned product |
| Recalls | Documented recall procedure; mock recall capability |
| Adverse event reporting | Procedure for identifying and reporting device-related AEs |
Consequences of Inspection Failure
| Outcome | Effect |
|---|---|
| Minor findings | Corrective action plan required; re-inspection scheduled |
| Major findings | CDAKB certificate suspended pending corrective actions |
| CDAKB suspension | All NIEs held by the entity are automatically frozen — no imports, no new distribution |
| CDAKB revocation | NIEs may be revoked; entity must fully re-certify |
Preparation Checklist
Before any CDAKB inspection (or at any time as an ongoing readiness check):
- CDAKB certificate and IDAK certificate current — check expiry dates
- All SOPs current, signed, version-controlled
- Temperature monitoring equipment calibrated and records available for at least 12 months
- Training records for all warehouse and distribution staff current
- Complaint log up to date; all complaints investigated and closed
- Last internal audit completed and findings addressed
- Mock recall completed within the past 12 months; results documented
- Traceability test: can you identify all customers who received a specific lot within 2 hours?