FDA 483 OBSERVATION · #1854 OF 1,916 MOST-CITED
Submittal of construction plans
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 submit plans for the major reconstruction of sanitation facilities at servicing areas to FDA for review.
Failure to submit plans for the construction of sanitary equipment and facilities to FDA for review.
Failure to submit plans for the construction of sanitation facilities at servicing areas to FDA for review.
Failure to submit plans for the construction of sanitation facilities at servicing areas to FDA for review.
Failure to submit plans for the construction of sanitation facilities at servicing areas to FDA for review.
Examples are a representative sample of FDA's published inspection observations. Open the 483 observation explorer →