FDA 483 OBSERVATION · #134 OF 1,923 MOST-CITED
SOPs not followed / documented
FDA cited this observation 220 times across 212 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.
Written production and process control procedures were not followed in execution, or were not documented at the time of performance, as required by §211.100(b) — the general CGMP expectation that the firm actually does what its SOPs say and records it contemporaneously.
Why FDA writes it — An SOP that is written but not followed provides no control at all, and a step performed but not documented cannot be proven to have happened. FDA protects against the gap between the paper system and the real one — the divergence where undocumented, unauthorized practice quietly replaces the validated process.
- Ensure written production and control procedures are followed as written and any deviation is documented and justified per §211.100(b).
- Record execution contemporaneously — at the time of performance — not reconstructed afterward.
- Route procedure changes through a controlled change process so the SOP in use matches current practice.
- Use internal audits and gemba observation to detect drift between the written procedure and floor practice.
- The written SOP is outdated relative to how the process is actually run, so operators follow undocumented practice.
- Records are completed at shift end from memory, breaking the contemporaneous-documentation requirement.
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 3.4× the rate of the average FDA-cited firm (26.4% vs 7.8%), across 212 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 production and process control procedures are not followed in the execution of production and process control functions.
Written production and process control procedures are not followed in the execution of production and process control functions.
Written production and process control procedures are not followed in the execution of production and process control functions and documented at the time of performance.
Written production and process control procedures are not followed in the execution of production and process control functions.
Written production and process control procedures are not followed in the execution of production and process control functions.
Written production and process control procedures are not followed in the execution of production and process control functions.
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 →