FDA 483 OBSERVATION · #945 OF 1,000 MOST-CITED
Establishment and Implementation of Monitoring Preventive Controls
FDA cited this observation 18 times across 17 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 monitoring, including adequate frequency for your preventive controls.
You did not establish written procedures for monitoring, including adequate frequency for your preventive controls.
You did not establish written procedures for monitoring, including adequate frequency for your preventive controls.
You did not establish written procedures for and implement monitoring, including adequate frequency for your preventive controls.
You did not establish written procedures for and implement monitoring, including adequate frequency for your preventive controls.
You did not establish written procedures for and implement monitoring, including adequate frequency for your preventive controls.
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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