Companies need to establish that their water system is adequately designed, controlled, maintained and monitored to ensure that it is consistently producing water for its intended use.
A flood of warning letters from the FDA on water system suitability could pull the plug on the production of food, beverage, cosmetic, nutraceutical and over-the-counter (OTC) or pharmaceutical products if companies are not conducting total organic carbon (TOC) water testing analysis on a regular basis.
Some FDA warning letters that have been issued call out companies that have failed to validate that their water systems consistently produced water suitable for its intended use. Companies need to establish that their water system is adequately designed, controlled, maintained and monitored to ensure that it is consistently producing water for its intended use. Those who fail to correct their water system can face regulatory or legal action, including seizures or an injunction. Unresolved violations may also prevent other federal agencies from awarding contracts. The FDA can also withhold the issuance of export certificates or the approval of new applications.