FDA 483 OBSERVATION · #995 OF 1,000 MOST-CITED
Written record not kept of program and validation data
FDA cited this observation 13 times across 12 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
A written record of the program along with appropriate validation data has not been maintained in situations where backup data is eliminated by computerization or other automated processes.
A written record of the program along with appropriate validation data has not been maintained in situations where backup data is eliminated by computerization or other automated processes.
A written record of the program along with appropriate validation data has not been maintained in situations where backup data is eliminated by computerization or other automated processes.
A written record of the program along with appropriate validation data has not been maintained in situations where backup data is eliminated by computerization or other automated processes.
A written record of the program along with appropriate validation data has not been maintained in situations where backup data is eliminated by computerization or other automated processes.
A written record of the program along with appropriate validation data has not been maintained in situations where backup data is eliminated by computerization or other automated processes.
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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