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Thereafter, ongoing vigilant oversight of process performance and product quality are necessary to ensure you maintain a stable manufacturing operation throughout the product lifecycle. 27 Regulations 21 CFR 211.84(d)(1) and 211.84(d)(2) remain a top citation in warning letters, and the agency continues to focus on risk of substitution or sub- or super-potent ingredients in OTC products like hand sanitizer

Ongoing supervision with baseline labs and periodic metabolic monitoring is treated as part of the package

The final decision always rests with the TSA officer

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Other ingredients Purified water, citric acid, phosphoric acid, malic acid, sucralose, natural & artificial flavors, preservative (less than 0.1% of potassium sorbate and sodium benzoate), FD&C blue #1

Mil Med Res (2022) 9:24