FDA 483 OBSERVATION · #1860 OF 1,916 MOST-CITED
Provisions to monitor lab test procedures & instruments
FDA cited this observation 5 times across 4 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
Failure to establish adequate provisions for monitoring the reliability, accuracy, precision and performance of laboratory test procedures and instruments.
Failure to establish adequate provisions for monitoring the reliability, accuracy, precision and performance of laboratory test procedures and instruments.
Failure to establish adequate provisions for monitoring the performance of laboratory test procedures and instruments.
Failure to establish adequate provisions for monitoring the reliability and performance of laboratory test procedures and instruments.
Failure to establish adequate provisions for monitoring the accuracy and precision and performance of laboratory test procedures and instruments.
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 →