FDA 483 OBSERVATION · #363 OF 1,000 MOST-CITED
Quality control production, process control; material review, disposition
FDA cited this observation 55 times across 53 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
Your quality control personnel did not conduct a material review and make a disposition decision for a specification established for the production and process control system that was not met.
Your quality control personnel did not conduct a material review and make a disposition decision for a specification established for the production and process control system that was not met.
Your quality control personnel did not conduct a material review and make a disposition decision for a specification established for the production and process control system that was not met.
Your quality control personnel did not conduct a material review and make a disposition decision for a specification established for the production and process control system that was not met.
Your quality control personnel did not conduct a material review and make a disposition decision for a specification established for the production and process control system that was not met.
Your quality control personnel did not conduct a material review and make a disposition decision for a specification established for the production and process control system that was not met.
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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