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Food and Drug Administration (FDA)
39
Transcript
Food and Drug Administration (FDA)
By: Lindsay & Haley
What does FDA regulate?
- Foods
- Human Prescription and Non-prescription Drugs
- Vaccines, Blood Products, & Other Biologics
- Medical Devices
- Electronic Devices
- Cosmetics
- Veterinary Products
- Tobacco Products
What does an audit involve?
Who does FDA regulate?
How often do they check for compliance?
- Audit is a documented independent inspection and review of a quality system
- Preformed on a periodic basis in accordance with written procedures
- It is to verify, by examination and evaluation of objective evidence.
- Very essential part of medical device manufacturer's effort to assure safe and effective devices
- Food manufacturers
- Human prescription and non-prescription drug manufacturers
- Vaccine and Blood Products, (etc) manufacturers
- Medical Device Manufacturers
- Electronic Product Manufacturers
- Cosmetic Manufacturers
- Veterinary Product Manufacturers
- Tobacco Product Manufacturers
- Depends on the product
- Spontaneously checks, could be weeks, months, a year
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