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Products under the jurisdiction of the US FDA include: food (21CFR 117), drugs (21CFR 211), medical devices (21CFR 820), radioactive products, biological preparations, animal equipment, cosmetics, and tobacco (PMTA tobacco). The quality system implements different standards according to different countries, and the United States implements different regulations for different products.
After the US FDA inspector arrives at the factory, the first meeting on the first day will be for the company to introduce the company. The English version of the introduction should be prepared and may include the following:
1) Company name, address, establishment date, number of people
2) US FDA registration information (FEI, role, registered product, 510(K) number, product listing number, product image, whether shipped, major US customers or importers)
3) Organization chart (position, name, photo)
4) Company qualifications (quality system certification, patents, product certification)
5) Company hardware (overall layout, floor plan layout, production & inspection equipment)
6) Process flow diagram (key processes and special processes) |
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