FDA 483 OBSERVATION · #207 OF 1,923 MOST-CITED
Supply-chain program - Assurance (Adequate)
FDA cited this observation 145 times across 138 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 1× the rate of the average FDA-cited firm (8.0% vs 7.8%), across 138 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
Your written supply-chain program does not provide assurance that a hazard requiring a supply-chain-applied control has been significantly minimized or prevented.
Your written supply-chain program does not provide assurance that a hazard requiring a supply-chain-applied control has been significantly minimized or prevented.
Your written supply-chain program does not provide assurance that a hazard requiring a supply-chain-applied control has been significantly minimized or prevented.
Your written supply-chain program does not provide assurance that a hazard requiring a supply-chain-applied control has been significantly minimized or prevented.
Your written supply-chain program does not provide assurance that a hazard requiring a supply-chain-applied control has been significantly minimized or prevented.
Your written supply-chain program does not provide assurance that a hazard requiring a supply-chain-applied control has been significantly minimized or prevented.
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 →