🇦🇺Australia

AICIS Record-Keeping Non-Compliance

1 verified sources

Definition

Personal care products require lot-level chemical inventory records for 5 years. Inadequate traceability during audits exposes firms to penalties under industrial chemicals laws.

Key Findings

  • Financial Impact: AUD 22,200 minimum civil penalty per contravention (AICIS enforcement)
  • Frequency: Per audit finding
  • Root Cause: Manual inventory lacking persistent lot traceability

Why This Matters

The Pitch: Personal care manufacturers in Australia 🇦🇺 face AUD 22,200+ fines per breach for poor lot traceability records. Automated inventory ensures compliance.

Affected Stakeholders

Compliance Officer, Manufacturing Director, Regulatory Affairs

Deep Analysis (Premium)

Financial Impact

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Current Workarounds

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Methodology & Sources

Data collected via OSINT from regulatory filings, industry audits, and verified case studies.

Evidence Sources:

Related Business Risks

Cost of Expired Product Shipments

AUD 5,000-20,000 per major return incident (refunds + disposal + lost margin)

Inventory Shrinkage from Poor Lot Tracking

1-3% of annual inventory value (AUD 50,000+ for mid-sized operations)

Cost of Poor Quality in Batch Production

AUD 20,000-100,000 per year in rework, disposal, and stability testing for SMEs (2-5% of production costs based on industry standards)

Capacity Loss from Quality Rework

AUD 10-40 hours per rework incident (AUD 500-2,000 at AUD 50/hr labor + overhead)

GMP Non-Compliance Audit Failures

AUD 5,000-20,000 per failed GMP audit (re-audit fees, consultant costs, production halts)

AICIS Non-Compliance Fines

Fines up to $10 million AUD for corporations; product recalls and market withdrawal.

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