FDA 483 OBSERVATION · #866 OF 1,000 MOST-CITED
Review of processing and production records
FDA cited this observation 21 times across 19 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
A processing record was not reviewed by a representative of plant management to determine whether the product received the scheduled process.
A processing record was not reviewed by a representative of plant management qualified by suitable training or experience to determine completeness of the record and whether the product received the scheduled process.
A processing and production record was not reviewed by a representative of plant management to determine completeness of the record and whether the product received the scheduled process.
A processing record was not reviewed by a representative of plant management to determine completeness of the record and whether the product received the scheduled process.
A processing and production record was not reviewed by a representative of plant management qualified by suitable training or experience to determine whether the product received the scheduled process.
A processing and production record was not reviewed by a representative of plant management qualified by suitable training or experience to determine completeness of the record and whether the product received the scheduled process.
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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