FDA 483 OBSERVATION · #689 OF 1,000 MOST-CITED
Criteria for establishing specifications
FDA cited this observation 24 times across 24 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 laboratory control processes for use of criteria for establishing appropriate specifications.
You did not follow laboratory control processes for use of criteria for establishing appropriate specifications.
You did not laboratory control processes for use of criteria for establishing appropriate specifications.
You did not follow laboratory control processes for use of criteria for establishing appropriate specifications.
You did not establish laboratory control processes for use of criteria for establishing appropriate specifications.
You did not follow laboratory control processes for use of criteria for establishing appropriate specifications.
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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