FDA 483 OBSERVATION · #81 OF 1,923 MOST-CITED
Procedures not adequately established or maintained
FDA cited this observation 326 times across 307 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 means, and how to comply
SPEQ's practitioner reading of this finding. The regulatory basis is a cited fact; the interpretation, compliance steps, and root causes are SPEQ synthesis — not an FDA classification of the citation.
A required device quality-system procedure was established but not adequately maintained — it existed at some point but had not been kept current, controlled, or effective, so it no longer adequately governed the activity.
Why FDA writes it — Under the device regulation, procedures must be both established and maintained. A procedure that once existed but has decayed — outdated, uncontrolled, or no longer matching practice — provides no real control, which FDA cites just as it would a missing procedure.
- Establish AND maintain the procedures the regulation requires — keeping them current, controlled, and effective.
- Manage procedure changes through document controls (21 CFR 820.40).
- Keep procedures aligned with actual practice so "maintained" is demonstrable.
- Verify through internal audit that procedures remain adequate and are followed.
- Procedures created once and never updated as processes and requirements changed.
- Uncontrolled procedure copies in use alongside the current version.
How to close this finding — and stop it recurring
What this observation is associated with
Firms cited for this observation also appear in FDA compliance actions — warning letters, injunctions, or seizures — at 1.5× the rate of the average FDA-cited firm (11.7% vs 7.8%), across 307 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
Document control procedures have not been adequately established.
Document control procedures have not been adequately established.
Document control procedures have not been adequately established.
Document control procedures have not been adequately established.
Document control procedures have not been adequately established.
Document control procedures have not been adequately established.
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 →