FDA 483 OBSERVATION · #620 OF 1,000 MOST-CITED
Written procedures followed
FDA cited this observation 28 times across 28 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
Procedures for the preparation of master production and control records are not followed.
Procedures for the preparation of master production and control records are not described in a written procedure.
Procedures for the preparation of master production and control records are not described in a written procedure.
Procedures for the preparation of master production and control records are not followed.
Procedures for the preparation of master production and control records are not described in a written procedure and followed.
Procedures for the preparation of master production and control records are not followed.
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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