FDA 483 OBSERVATION · #930 OF 1,932 MOST-CITED
All core requirements covered in program
FDA cited this observation 19 times across 18 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.
What this grouping is not
An observation-type page groups FDA’s published citation records. The grouping, the compliance steps and the root causes are SPEQ synthesis, not an FDA classification of any citation, and a count measures what FDA published rather than risk.
How FDA worded it — real examples
A quality program which addresses all of the core CGTP requirements, appropriate for the HCT/Ps manufactured and the manufacturing steps performed, has not been established and maintained.
A quality program which addresses all of the core CGTP requirements, appropriate for the HCT/Ps manufactured and the manufacturing steps performed, has not been defined and followed.
A quality program which addresses all of the core CGTP requirements, appropriate for the HCT/Ps manufactured and the manufacturing steps performed, has not been established.
A quality program which addresses all of the core CGTP requirements, appropriate for the HCT/Ps manufactured and the manufacturing steps performed, has not been defined and followed.
A quality program which addresses all of the core CGTP requirements, appropriate for the HCT/Ps manufactured and the manufacturing steps performed, has not been maintained, defined, documented, implemented and followed.
A quality program which addresses all of the core CGTP requirements, appropriate for the HCT/Ps manufactured and the manufacturing steps performed, has not been established.
Examples are a representative sample of FDA's published inspection observations. Open the 483 observation explorer →