FDA 483 OBSERVATION · #905 OF 1,000 MOST-CITED
Records of process establishment
FDA cited this observation 16 times across 16 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
Complete records covering all aspects of the establishment of the scheduled process were not prepared by the person or organization making the determination.
Complete records covering all aspects of the establishment of the scheduled process were not prepared and permanently retained by the person or organization making the determination.
Complete records covering all aspects of the establishment of the scheduled process were not permanently retained by the person or organization making the determination.
Complete records covering all aspects of the establishment of the scheduled process were not prepared and permanently retained by the person or organization making the determination.
Complete records covering all aspects of the establishment of the scheduled process were not prepared and permanently retained by the person or organization making the determination.
Complete records covering all aspects of the establishment of the scheduled process were not prepared by the person or organization making the determination.
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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