FDA 483 OBSERVATION · #335 OF 1,932 MOST-CITED
Record retention
FDA cited this observation 84 times across 81 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 1.4× the rate of the average FDA-cited firm (11.1% vs 7.8%), across 81 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
You did not retain records as required.
Copies of required records were not maintained.
You did not retain records as required.
Your monitoring, corrective action and verification records are not maintained at your facility for at least the required time period.
Investigational records were not retained for a period of two years following approval of a drug's marketing application and discontinuance of the investigation and notification of FDA.
You did not prepare, review, and retain required processing and production records at the processing plant or other reasonably accessible location and for three years from the date of manufacture.
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 →