FDA 483 OBSERVATION · #941 OF 1,000 MOST-CITED
Production controls not adequate
FDA cited this observation 15 times across 15 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
Production controls do not include documentation of procedures and methods for the control of production and implementation of monitoring and measurement of process parameters and product characteristics.
Production controls do not include documentation of procedures and methods for the control of production.
Production controls do not include documentation of procedures and methods for the control of production.
Production controls do not include qualification of infrastructure.
Production controls do not include documentation of procedures and methods for the control of production, implementation of monitoring and measurement of process parameters and product characteristics and implementation of defined operations for labeling and packaging.
Production controls do not include documentation of procedures and methods for the control of production.
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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