FDA 483 OBSERVATION · #968 OF 1,932 MOST-CITED
Process validation procedures
FDA cited this observation 18 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
Procedures to validate and approve processes that cannot be fully verified by inspection and tests were not established.
Procedures to validate and approve processes that cannot be fully verified by inspection and tests were not established.
Procedures to validate and approve processes that cannot be fully verified by inspection and tests were not established, defined and documented.
Procedures to validate and approve processes that cannot be fully verified by inspection and tests were not established, defined and documented.
Procedures to validate and approve processes that cannot be fully verified by inspection and tests were not defined.
Procedures to validate and approve processes that cannot be fully verified by inspection and tests were not established.
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. Open the 483 observation explorer →