FDA 483 OBSERVATION · #928 OF 1,000 MOST-CITED
Investigator device accountability inadequate
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
Records of use of a device that relate to the dates of receipt and batch number or code mark of the device are not all accurate and complete.
Records of use and disposal of a device that relate to the batch number or code mark of the device are not all accurate and complete.
Records of receipt, use and disposal of a device that relate to the type and quantity, dates of receipt and batch number or code mark of the device are not all accurate, complete and current.
Records of receipt, use and disposal of a device that relate to the type and quantity, dates of receipt and batch number or code mark of the device are not all complete.
Records of receipt, use and disposal of a device that relate to the type and quantity, dates of receipt and batch number or code mark of the device are not all accurate.
Records of receipt, use and disposal of a device that relate to the batch number or code mark of the device are not all accurate and complete.
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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