• The FDA's job is to keep food and drugs safe for consumption.food image by saied shahinkiya from Fotolia.com
  
  The Food and Drug Administration (FDA) falls under the jurisdiction of the U. S. Department of Health and Human Services. It performs inspections to guarantee food, drugs, cosmetics, tobacco, biological and radioactive products, and medical devices are safe for public use. The FDA categorizes its inspections in four different ways: drug, food, and team or solo inspections.
  
  

Food Inspections

• In accordance with the Food, Drug, and Cosmetic Act, FDA entomologists, chemists, sanitarians, and food microbiologists inspect food-manufacturing establishments to prevent food not suitable for consumption from entering the market. The FDA considers unsafe foods those that have been treated with pesticides and industrial-grade chemicals or that have been dyed or altered with additives illegally. In addition, the FDA bars foods that aren't clean or that have begun to decompose.
  Food manufacturers must also follow the FDA's "Good Manufacturing Practices" regarding water and contact surfaces used during food production. Inspectors verify that the water is not being reused and that it does not contain any of the following pathogens: Escherichia coli, Salmonella, Vibrio cholerae, Shigella, Cryptosporidium parvum, Giardia lamblia, Cyclospora cayetanensis, Toxiplasma gondii, and the Norwalk and hepatitis A viruses. FDA investigators also look for evidence that surfaces used for food preparation are sanitized with methods that kill organisms that cause food-borne illnesses.
  
  

Drug Inspections

• The FDA inspects pharmaceutical laboratories to guarantee the safety of their products. Among the items inspectors review are the lab's procedures for receiving, sampling, and assigning samples of raw material used in drug production. In addition, they visually examine receiving and storage areas and compare written records of operation against the lab's actual methods of operation. The FDA also examines drug-testing information and chooses drugs from specific lots to undergo a thorough review of all its data. Besides product inspection, the Food and Drug Administration is responsible for checking pharmaceutical manufacturing equipment for proper calibration and sterility.
  Inspectors also review a lab's stability program, which determines how long drugs remain viable for consumption so an expiration date can be established. In addition, they verify that employees have received the required training for the type of work they perform in the lab.
  
  

Team and Solo Inspections

• The FDA often performs inspections as a team, which includes any combination of the following staff: analysts, investigators, microbiologists, chemists, and compliance officers. In the case of a group inspection, a lead investigator heads the team while the analyst records the team members' observations according to the FDA's "Investigations Operations Manual." In a team inspection, the analyst writes the final report but the lead investigator has the right to edit it for style.
  Sometimes, an analyst is also assigned to do a solo inspection, becoming the lead investigator by default. He conducts his investigation and reaches conclusions based on the guidelines of the "Investigations Operations Manual." If he finds violations in a food or drug-manufacturing company, the analyst should consult with his district office manager for guidance on how to proceed regarding penalties and correction plans.