Medline Audit
Medline is LaParty Vietnam's medical device customer, primarily purchasing Specimen Bags. Medline conducts dual-track audits covering Quality (QA) per FDA 21 CFR Part 820 (QSR) and ISO 13485, as well as Social Accountability (SA8000).
Audit History
| Audit Type | Date | Notes |
|---|---|---|
| Medline QA Audit (factory visit) | January 18–19, 2024 | Two-day on-site audit; preparatory visit on Jan 17 |
| Medline Social Accountability (SA8000) | August 20, 2024 | SA training and inspection |
| Medline Human Rights Audit | January 2024 (initial) | Human rights documents review |
| Medline Human Rights Audit | February 18–19, 2025 | SCAPA evaluation (VN Level 2) |
Primary Product Supplied
- Specimen Bag: Medical device for the US market
- Manufacturing process: Blown Film + Sealing & Cutting
FDA Information
| Item | Details |
|---|---|
| FDA Registration No. (2023) | 3018773935 |
| 2024 FDA Registration | Renewal in progress |
| e-MDR Account | None (confirmed by FDA agent) |
| FDA 483 Form | None (factory has not been directly inspected by FDA) |
Quality Audit Document Checklist (January 18–19, 2024)
Based on Medline Desk Review Audit Checklist (Rev. 03212023):
| No. | Required Item | Factory Documents | Status / Notes |
|---|---|---|---|
| 1 | FDA Registration | FDA Registration No. 3018773935 | Provided |
| 2 | FDA audit / 483 form | No FDA direct audit record | Partly provided |
| 3 | Business license, ISO certificates | Vietnam factory license, ISO 9001, ISO 22000 | Provided |
| 4 | Employee information (child labor check) | Employee roster, files, QC department list | In progress |
| 5 | US market export history | Specimen bags for Medline | Pending confirmation |
| 6 | Products manufactured / supplied to Medline | Specimen Bag | Confirmed |
| 8 | Quality Manual, objectives, management commitment | Management commitment procedure; quality and food safety objectives and policy | Need to update to audit date |
| 9 | Management review procedure and reports (min. 2) | Management review procedure; management review meeting minutes | Ready |
| 10 | Internal audit procedure and reports (min. 2) | Internal audit procedure, records, consolidated report | Only one report available (first year) |
| 11 | CAPA procedure and records (min. 3) | Corrective action procedure, quality anomaly forms, corrective tracking forms | Need to confirm if format qualifies as CAPA |
| 12 | Complaint procedure and records | Customer satisfaction procedure, quality anomaly forms | Need to confirm if it qualifies as complaint procedure |
| 13 | MDR (Medical Device Report) procedure | No e-MDR account (confirmed by FDA agent) | Inform auditor accordingly |
| 14 | Recall procedure | Product traceability and recall management procedure | Confirm any recall cases |
| 15 | Design control (DHF) | Factory does not participate in design; Medline indicated likely exemption | Pending Medline confirmation |
| 16 | Risk management | HACCP manual, OPRP/HACCP plan confirmation records, verification analysis report | Pending confirmation |
| 17 | Training and HR management | Training management procedure, annual training plan; ISO 13485/21CFR820 training not yet conducted | Plan to arrange consultant-led ISO 13485 training |
| 18 | Document control | Document management procedure, document/form register, distribution/recovery register, external document list | Ready |
| 19 | Record control (including retention periods) | Document management procedure; equipment records to be kept 2 years | Pending confirmation |
| 20 | Environmental and pest control | Pest control procedure, mosquito lamp/mouse trap records, cleaning schedules, 5S check sheets | Ready |
| 21 | Measuring instrument calibration | Instrument management procedure, calibration plan, instrument list, internal/external calibration reports | Ready |
| 22 | Manufacturing equipment maintenance | Equipment management procedure, maintenance schedule, equipment history card | Ready |
| 23 | Production flow chart | Production flow chart (Vietnam factory version) | Ready |
| 24 | Process validation | Blown film and sealing/cutting temperature parameter tables (no formal validation report) | Medline: findings if no process validation report |
| 25 | Validated parameter cards | Blown film and sealing/cutting temperature parameter tables | Pending confirmation |
| 26 | Change control (ECN) | No formal ECN procedure; Medline listed as observation | Pending consultant template |
| 27 | Device Master Record (DMR) | Existing procedure documents largely sufficient; details to supplement | Under review |
| 28 | Raw material inspection (IQC) | Plastic resin receiving inspection forms (HD, LD, LLD) | Ready |
| 29 | In-process inspection (IPQC) | Process inspection records | Ready |
| 30 | Finished goods inspection (FQC) | Finished goods inspection report | Ready |
| 31 | Device History Record (DHR) | Equipment history card, daily check sheet, daily maintenance record | Ready |
| 32 | Traceability | Pre-shipment finished goods inspection and retention management procedure | Ready |
| 33 | Product identification | Production work order (includes machine no., order no., product no.); traceability code | Ready |
| 34 | Purchasing control / supplier evaluation | Purchasing procedure, supplier management procedure, approved supplier list, annual supplier assessment, sample verification report, supplier quality agreement | Sample verification report and guarantee letter required |
| 35 | Non-conformance control | Non-conformance control procedure, quality anomaly forms, corrective tracking forms | Medline-specific version needed |
| 36 | Labeling control and packaging | Production work order, carton printing instruction, scrap form | Under confirmation |
| 37 | Line clearance control | Blown film and sealing/cutting major cleaning schedule | Ready |
On-Site Findings (January 18, 2024)
Findings from audit day and corrective actions documented in:
240118 當天巡廠缺失 Before&After-已更正.pptx(findings before & after correction)- Rework records form (240118 version)
Social Accountability Audit (August 20, 2024)
- Video recordings:
20240820_103821_1.mp4through_4.mp4 - Training journal:
Medline 培訓日誌-240820.docx
Human Rights Audit (February 18–19, 2025)
| Item | Details |
|---|---|
| Evaluating Body | SCAPA (Sedex Members Ethical Trade Audit) |
| Report Name | SCAPA_LA Party Corporation Vietnam Company Limited_02-18-2025 |
| Documents Used | VN Level 2 Documents Request List (Chinese status version dated Feb 11, 2025) |
| HR Checklist | Human Rights Checklist (Vietnamese + Chinese, dated Jan 22, 2025) |
SA8000 Document Package
2024 January SA8000 review (240108 Medline 人權) includes:
- New factory floor plan
- Process Flow Diagram (production flow)
- Organizational chart (including HACCP team)
- Union organizational chart and charter
- Wage structure documentation
- Attendance, payroll, and social insurance records (12 months)
- Employee contract template, employee handbook, resignation policy
- Factory lease agreement
- Fire safety compliance records, fire drill documentation, evacuation route map
- Water quality test report (SGS)
- Environmental impact assessment certificate, construction permit, property completion certificate
Priority Improvement Items
- Process Validation Reports (item 24): Formal blown film and sealing/cutting process validation reports required (process design, qualification, and ongoing validation)
- ISO 13485 / 21CFR820 Training: Arrange consultant-led training; QA Manager to attend external certification course
- Device Master Record (DMR): Confirm all documents (equipment history cards, work instructions, process control procedures) cover all 21 CFR 820.181 requirements
- Equipment Record Retention Period: Update all equipment-related records to 2-year retention
- CAPA and Non-Conformance Records: Create Medline-specific version of corrective tracking forms