FDA 483 OBSERVATION · #809 OF 1,000 MOST-CITED
Written procedures - laboratory operations
FDA cited this observation 23 times across 22 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 follow written procedures for laboratory operations.
You did not establish written procedures for laboratory operations.
You did not follow written procedures for laboratory operations.
You did not establish and follow written procedures for laboratory operations.
You did not establish written procedures for laboratory operations.
You did not establish and follow written procedures for laboratory operations.
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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