FDAnews Device Daily Bulletin

Manufacturers can avoid inadvertently doing business with show-and-shadow factories by scrutinizing foreign suppliers’ paperwork and specific details of their operations. When contracting with a foreign supplier, devicemakers should audit the supplier’s use of raw materials and the number of personnel versus the claimed output, FDA spokeswoman Crystal Rice said. Supplier audits should verify that the manufacturing capacity and technology are as the supplier described to the relevant regulatory authority in device master files, site master files and marketing applications.
The GMP Letter