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| QUALITY
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| AUDIT |
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| SUPPLIER
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| PRODUCTS &
CLIENTS |
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| ABOUT AMREP |
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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:
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Insulin/Diabetic Blood Measuring
Instrument
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Blood Transfusion and Transfer Machine
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Handicapped Mobile Scooters
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Hospital mechanized Beds
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Exercise and Orthopedic Equipment
Work has also been done in Taiwan and Japan.
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