FDA 483 OBSERVATION · #8 OF 1,923 MOST-CITED
Procedures not in writing, fully followed
FDA cited this observation 1,478 times across 1,241 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.
Production and process-control procedures either were not established in writing, or were written but not actually followed in the execution of the work — including deviations from procedures that were not recorded and justified.
Why FDA writes it — GMP requires that written procedures be drawn up and followed so that the drug product has the identity, strength, quality, and purity it claims. A procedure that exists on paper but is not followed gives no assurance the batch was made under control — and undocumented deviation is the most common way a validated process quietly stops being validated.
- Establish written procedures for production and process control, designed to assure the products have the identity, strength, quality, and purity they purport to possess.
- Follow the procedures in execution, and document that they were followed — records made at the time the activity is performed.
- Where a deviation from a written procedure occurs, record and justify it at the time, rather than reconstructing it later.
- Keep procedures current with actual practice so “followed” is achievable and truthful.
- The floor evolved the process but the controlled procedure was never revised, so practice and procedure diverge.
- Deviations handled informally in the moment and never documented, so the record cannot show the procedure was followed.
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 3.7× the rate of the average FDA-cited firm (28.6% vs 7.8%), across 1,241 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
The responsibilities and procedures applicable to the quality control unit are not fully followed.
The responsibilities and procedures applicable to the quality control unit are not fully followed.
The responsibilities and procedures applicable to the quality control unit are not fully followed.
The responsibilities and procedures applicable to the quality control unit are not fully followed.
The responsibilities and procedures applicable to the quality control unit are not fully followed.
The responsibilities and procedures applicable to the quality control unit are not in writing and fully followed.
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 →