FDA 483 OBSERVATION · #56 OF 1,923 MOST-CITED
Written procedures not established/followed
FDA cited this observation 443 times across 398 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 procedures required by the quality system were not established, or were established but not followed — a general finding that the controlling documents for an activity either did not exist or were not adhered to in practice.
Why FDA writes it — Established-and-followed is the two-part test for a written procedure. Failing either half means the activity is not under documented control — so this is one of the most common findings across drug and device operations, and it usually underlies other, more specific observations.
- Establish the written procedures the regulation requires for the activity, with the necessary scope and detail.
- Follow the procedures in practice, and record that they were followed.
- Keep procedures current with actual practice so adherence is achievable.
- Train personnel to the procedures and document the training.
- Procedures exist but practice has drifted from them, so they are not actually followed.
- Required procedures were never established for an activity done informally.
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 4.5× the rate of the average FDA-cited firm (34.9% vs 7.8%), across 398 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 procedures are not established for the cleaning and maintenance of equipment, including utensils, used in the manufacture, processing, packing or holding of a drug product.
Written procedures are not established for the cleaning and maintenance of equipment, including utensils, used in the manufacture, processing, packing or holding of a drug product.
Written procedures are not established and followed for the cleaning and maintenance of equipment, including utensils, used in the manufacture, processing, packing or holding of a drug product.
Written procedures are not established and followed for the cleaning and maintenance of equipment, including utensils, used in the manufacture, processing, packing or holding of a drug product.
Written procedures are not established and followed for the cleaning and maintenance of equipment, including utensils, used in the manufacture, processing, packing or holding of a drug product.
Written procedures are not established and followed for the cleaning and maintenance of equipment, including utensils, used in the manufacture, processing, packing or holding of a drug product.
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 →