FDA 483 OBSERVATION · #167 OF 1,923 MOST-CITED
Items to cover on annual reviews
FDA cited this observation 187 times across 174 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 4.5× the rate of the average FDA-cited firm (35.1% vs 7.8%), across 174 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
Written procedures are not established for evaluations done at least annually and including provisions for a review of complaints, recalls, returned or salvaged drug products and investigations conducted for each drug product.
Written procedures are not followed for evaluations done at least annually and including provisions for a review of complaints, recalls, returned or salvaged drug products and investigations conducted for each drug product.
Written procedures are not established for evaluations done at least annually and including provisions for a review of complaints, recalls and returned or salvaged drug products.
Written procedures are not established for evaluations done at least annually and including provisions for a review of complaints, recalls, returned or salvaged drug products and investigations conducted for each drug product.
Written procedures are not followed for evaluations done at least annually and including provisions for a review of investigations conducted for each drug product.
Written procedures are not established and followed for evaluations done at least annually and including provisions for a review of complaints and investigations conducted for each drug product.
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 →