FDA 483 OBSERVATION · #831 OF 1,000 MOST-CITED
Equipment - establish written procedures
FDA cited this observation 18 times across 18 firms in recent inspections. Below: how it breaks down by program area and fiscal year, and real examples of how FDA worded it on Form FDA 483.
How FDA worded it — real examples
You did not establish written procedures for fulfilling the requirements for calibrating, inspecting, and checking automated, mechanical, and electronic equipment.
You did not establish written procedures for fulfilling the requirements for calibrating instruments and controls that you use in manufacturing or testing a component or dietary supplement, calibrating, inspecting, and checking automated, mechanical, and electronic equipment and maintaining, cleaning, and sanitizing, equipment, utensils, and any other contact surfaces that are used to manufacture, package, label, or hold components or dietary supplements.
You did not establish written procedures for fulfilling the requirements for maintaining, cleaning, and sanitizing, equipment, utensils, and any other contact surfaces that are used to manufacture, package, label, or hold components or dietary supplements.
You did not establish written procedures for fulfilling the requirements for calibrating, inspecting, and checking automated, mechanical, and electronic equipment and maintaining, cleaning, and sanitizing, equipment, utensils, and any other contact surfaces that are used to manufacture, package, label, or hold components or dietary supplements.
You did not establish written procedures for fulfilling the requirements for calibrating instruments and controls that you use in manufacturing or testing a component or dietary supplement, calibrating, inspecting, and checking automated, mechanical, and electronic equipment and maintaining, cleaning, and sanitizing, equipment, utensils, and any other contact surfaces that are used to manufacture, package, label, or hold components or dietary supplements.
You did not establish written procedures for fulfilling the requirements for maintaining, cleaning, and sanitizing, equipment, utensils, and any other contact surfaces that are used to manufacture, package, label, or hold components or dietary supplements.
Related SPEQ references
Where to read the requirements behind this observation area on SPEQ. These are SPEQ's topic and audience pages — not an FDA classification of the citation.
Examples are a representative sample of FDA's published inspection observations. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data.
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