FDA 483 OBSERVATION · #542 OF 1,000 MOST-CITED
Verification - CCP, CA record review
FDA cited this observation 34 times across 30 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 review all of your critical control point monitoring records within one week (7 days) of the day the records are made.
You did not review all of your critical control point monitoring records within one week (7 days) of the day the records are made.
You did not review your critical control point monitoring records within one week (7 days) of the day the records are made.
You did not review all of your critical control point monitoring records within one week (7 days) of the day the records are made.
You did not review all of your critical control point monitoring records within one week (7 days) of the day the records are made.
You did not review all of your critical control point monitoring records within one week (7 days) of the day the records are made.
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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