The most challenging aspect of an FDA inspection is that the standard that the inspector is auditing to is so vague, non-technical, and open to interpretation that a company can be audited three times by three different inspectors with three completely different outcomes. It is the "C" in front of "GMP" that will bring your company down in an inspection. The challenges just to a pharmaceutical QC laboratory such as ours are daunting: 1) USP standards aren't certified reference materials, but are proprietary consensus standards for which characterization data is unavailable to the user. As such, they aren't compliant to the industry standard for testing laboratories: ISO 17025. 2) Many USP methods contain gross scientific errors and can not pass a method validation challenge to demonstrate suitability for their use for the specifications USP materials are expected to meet. 3) The FDA places such significant obstacles to continuous improvement that they have kept the industry in the "dark ages" from a technological perspective. With public outcry that the FDA is to blame for every act of industry quality failure and an increased mandate to keep the public safe, the FDA finds itself trying to "inspect in quality" without the resources and tools to be effective. Given a lack of specific standards, companies find themselves trying to hit a moving target without any assurance that they are on the right track. "More must be better" ends up driving industry consolidation (smaller companies can't afford to implement the quality systems of larger companies) and increased costs to the consumer, without an assurance of higher quality of the final product.