FDA 483 OBSERVATION · #1188 OF 1,932 MOST-CITED
Manufacturer instructions not followed
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.
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
Testing for communicable disease agents was not performed in accordance with the manufacturer's instructions.
Testing for communicable disease agents was not performed in accordance with the manufacturer's instructions.
Testing for communicable disease agents was not performed in accordance with the manufacturer's instructions.
Testing for communicable disease agents was not performed in accordance with the manufacturer's instructions.
Testing for communicable disease agents was not performed in accordance with the manufacturer's instructions.
Testing for communicable disease agents was not performed in accordance with the manufacturer's instructions.
Examples are a representative sample of FDA's published inspection observations. Open the 483 observation explorer →