FDA 483 OBSERVATION · #1220 OF 1,932 MOST-CITED
Retention time (10 year rules)
FDA cited this observation 12 times across 11 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
Records were not retained for the appropriate length of time, 10 years after their creation.
Records were not retained for the appropriate length of time, 10 years after their creation.
Records were not retained for the appropriate length of time, 10 years after their creation.
Records were not retained for the appropriate length of time, at least 10 years after the date of a particular HCT/Ps distribution, disposition, or expiration, whichever is latest, when the date of administration is not known.
Records were not retained for the appropriate length of time, 10 years after their creation.
Records were not retained for the appropriate length of time, 10 years after their creation.
Examples are a representative sample of FDA's published inspection observations. Open the 483 observation explorer →