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CDRRHR Inspections

PH-Unique · FDA Philippines · Regional Field Offices · LTO compliance

Overview​

CDRRHR conducts inspections of licensed establishments to verify ongoing compliance with LTO conditions, QMS requirements, and post-market obligations. Inspections may be routine, triggered by complaints, or follow-up after adverse events.

Types of Inspections​

Inspection TypeTrigger
Routine LTO inspectionPart of LTO issuance and renewal cycle
Market surveillanceConducted by CDRRHR and Regional Field Offices as ongoing market monitoring
Complaint-triggered inspectionInitiated following a complaint or adverse event report
Post-FSCA inspectionFollow-up after a field safety corrective action
Import inspectionInspection at port of entry coordinated with Bureau of Customs

What Inspectors Assess​

During an establishment inspection, CDRRHR evaluators will typically review:

  • Validity of LTO and compliance with LTO conditions
  • Storage conditions — temperature, humidity, segregation of approved and rejected stock
  • Distribution records — traceability of devices from receipt to sale
  • Complaint handling records — complaint log, investigation records, CAPA
  • Adverse event reports — eReport submissions and case files
  • Recall records — recall procedures, execution records
  • CMDN/CMDR certificates — validity and correspondence with products being distributed

Regional Field Office Monitoring — PH-Unique​

CDRRHR has Regional Field Offices throughout the Philippines that conduct localised market surveillance. This means:

  • Compliance monitoring is decentralised — products distributed outside Metro Manila are subject to regional inspection
  • A compliant establishment in Manila may still have products identified as non-compliant through regional field office activity
  • Maintain distribution records and ensure your regional distributors / sub-distributors are informed of their compliance obligations

Responding to Inspection Findings​

If CDRRHR identifies deficiencies during an inspection:

  1. A written Notice of Deficiency is issued
  2. The establishment must respond with a CAPA plan within the specified timeframe
  3. CDRRHR may conduct a follow-up inspection to verify CAPA implementation
  4. Failure to respond or repeated non-compliance may lead to:
    • Suspension of LTO
    • Revocation of LTO
    • Recall of affected products
    • Criminal prosecution under RA 9711

Preparing for Inspection​

Best practices to maintain inspection-ready status:

  • Keep LTO, CMDN/CMDR certificates, and ISO 13485 certificates filed and readily accessible
  • Maintain an up-to-date distribution record for each registered product
  • Ensure the complaint log is current and all complaints have documented investigation and CAPA
  • Storage logs (temperature monitoring records, if applicable) must be maintained
  • Train all staff on procedures for welcoming and cooperating with CDRRHR inspectors

Penalties for Non-Compliance — RA 9711​

Violations identified during inspection may lead to administrative and criminal penalties under RA 9711, including:

  • Fines up to ₱500,000 per violation
  • Revocation of LTO
  • Product seizure
  • Imprisonment for responsible officers in cases of deliberate falsification or serious violations

See Compliance & Enforcement.