FDA Inspector Procedures

Water System Purity Inspections
For purified water systems, inspectors certify that the water complies with the Environmental Protection Agency's regulations for drinking water. If the water only reaches minimal standards, it will also be tested for microbial organisms. Any water sample that contains over 100 microbial organisms per milliliter of water is unacceptable.
Inspectors will also test for "objectionable organisms," which are organisms that cause infections and diseases that are resistant to drugs and other forms of treatment. The presence of or traces of any objectionable organisms will disqualify the entire water sample. Water purity inspectors will note the type of purification system used. Two forms of acceptable treatment include Reverse Osmosis filtration and Ultra Filtration, which is used to reduce the presence of endotoxins.
Topical Drug Product InspectionsTopical drugs are medications that are applied to the exterior of the body and not ingested. Topical medications are usually rubs or creams that are applied to the skin, or to the outside of the throat.
Inspectors of topical drugs consider how the product reacts to changes in heat. If the product degrades or causes insoluble ingredients to dissolve or change in size and form, it must be noted on the product label.
Inspectors will investigate if deionizing systems were used to produce purified water that was used in the product. Factors such as the microbial quality of the water and chlorine levels as well as ion residual levels are noted as well.
Food Processing and Sterilization Packaging InspectionsWhile inspecting food processing and Sterilization Packaging facilities, FDA inspectors refer to a diagram or blueprint of the processing and Sterilization Packaging system, along with a guided review of the entire system. The inspectors look at a process flow diagram as well as incoming raw materials that are entering the processing facility. They review the sterilization processes. If the facility uses more than one aseptic processing system, the system that is most at risk for contamination should be inspected.
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