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Medical devices manufacturers “fear” FDA inspections as well. Companies which have never had an FDA inspection often don't know how such an inspection isFDA Compliance Program Guidance Manual Chapter – 45 Biological Drug Products Inspection of Biological Drug Products (CBER) 7345.848. Internet:. Compliance Policy Guide Sec. 130.300 FDA Access to Results of Quality Assurance Program Audits and Inspections (CPG 7151.02) was revised on June 2, 2007, ❒ Investigations Operations Manual (IOM). ❒ Code of Federal Regulations, Title 21 (21 CFR) Part 820 Quality. System Regulation; Part 803 Medical Device
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