AMREP INSPECT Global Supplier Management
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Qualifying FDA Bio-medical Suppliers

An AMREP FDA specialist team now handles audits of Asian suppliers which want to or are supplying to US pharmaceutical, medical and equipment suppliers. Many new Chinese suppliers of pharmaceutical products have appeared in China. Most have to meet FDA approval regulations and qualifications. Some customers have started using AMREP to audit and survey these new suppliers before being selected by US customers into their plans to use them as FDA approved and certified suppliers. AMREP audits and survey visits have identified suppliers which could not pass FDA requirements but have managed to secure contracts with US pharmaceutical and medical companies through other sources. Some customers using our supplier inspection services in Asia include Invensys, Bayer, and KV Pharmaceutical. Here are some products that AMREP has worked on:
  • Insulin/Diabetic Blood Measuring Instrument
  • Blood Transfusion and Transfer Machine
  • Handicapped Mobile Scooters
  • Hospital mechanized Beds
  • Exercise and Orthopedic Equipment

Work has also been done in Taiwan and Japan.

  1. Automotive Parts Inspection
  2. Inspecting PDA's and Cell Phone Production
  3. Outsourcing Blackholes in China and Everywhere
  4. Qualifying FDA Bio-medical Suppliers
  5. Effective Outsourced Supplier Management
  6. Don't be Trapped by a Supplier
For customers who need FDA approval for their products:
Lawrence Khoo

For more information contact:
Isabel Ingco
USA: +1 800 692 8539


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