FDA 483 OBSERVATION · #271 OF 1,923 MOST-CITED
Onsite audit
FDA cited this observation 110 times across 102 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.
What this observation is associated with
Firms cited for this observation also appear in FDA compliance actions — warning letters, injunctions, or seizures — at 3.2× the rate of the average FDA-cited firm (24.5% vs 7.8%), across 102 FEI-matched firms.
This is an association, not causation, and reflects co-occurrence in FDA's records — not a claim that the observation caused or preceded the action.
How FDA worded it — real examples
For a food that may contain a hazard that will be controlled by the foreign supplier and is one for which there is a reasonable probability that exposure to the hazard will result in serious adverse health consequences or death to humans or animals, you did not conduct and document or obtain documentation of an onsite audit of the foreign supplier.
For a food that may contain a hazard that will be controlled by the foreign supplier and is one for which there is a reasonable probability that exposure to the hazard will result in serious adverse health consequences or death to humans or animals, you did not conduct and document or obtain documentation of an onsite audit of the foreign supplier.
For a food that may contain a hazard that will be controlled by the foreign supplier and is one for which there is a reasonable probability that exposure to the hazard will result in serious adverse health consequences or death to humans or animals, you did not conduct and document or obtain documentation of an onsite audit of the foreign supplier.
For a food that may contain a hazard that will be controlled by the foreign supplier and is one for which there is a reasonable probability that exposure to the hazard will result in serious adverse health consequences or death to humans or animals, you did not conduct and document or obtain documentation of an onsite audit of the foreign supplier before initially importing the food into the United States.
For a food that may contain a hazard that will be controlled by the foreign supplier and is one for which there is a reasonable probability that exposure to the hazard will result in serious adverse health consequences or death to humans or animals, you did not conduct and document or obtain documentation of an onsite audit of the foreign supplier before initially importing the food into the United States and at least annually after importing the food into the United States.
For a food that may contain a hazard that will be controlled by the foreign supplier and is one for which there is a reasonable probability that exposure to the hazard will result in serious adverse health consequences or death to humans or animals, you did not conduct and document or obtain documentation of an onsite audit of the foreign supplier at least annually after importing the food into the United States.
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 →