FDA 483 OBSERVATION · #22 OF 1,923 MOST-CITED
Absence of Written Procedures
FDA cited this observation 831 times across 707 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 written procedure that the regulation requires simply did not exist. Distinct from an inadequate procedure, this is the outright absence of the SOP, work instruction, or defined method for a regulated activity.
Why FDA writes it — Many GMP and QSR requirements are explicit that a written procedure “shall be established.” When none exists, the activity is uncontrolled by definition and there is no basis on which people can perform it consistently — so the absence is a direct regulatory violation, not a matter of degree.
- Identify every activity for which the regulation explicitly requires a written procedure, and confirm each one exists, is approved, and is current.
- Establish the missing procedure with the required scope, responsibilities, and acceptance criteria before the activity is performed.
- Train personnel to the procedure and record the training.
- Include the procedure in the document-control system so it stays current.
- A required procedure was never created because the activity “was always done a certain way” informally.
- A regulatory requirement to have a specific written procedure was not mapped to an owned, controlled document.
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 5.1× the rate of the average FDA-cited firm (39.5% vs 7.8%), across 707 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
Your firm failed to establish adequate written procedures for production and process controls designed to assure that the drug products have the identity, strength, purity, and quality that they are purported or represented to possess.
Your firm failed to establish written procedures for production and process controls designed to assure that the drug products have the identity, strength, purity, and quality that they are purported or represented to possess.
Your firm failed to establish written procedures for production and process controls designed to assure that the drug products have the identity, strength, purity, and quality that they are purported or represented to possess.
Your firm failed to establish written procedures for production and process controls designed to assure that the drug products have the identity, strength, purity, and quality that they are purported or represented to possess.
Your firm failed to establish adequate written procedures for production and process controls designed to assure that the drug products have the identity, strength, purity, and quality that they are purported or represented to possess.
Your firm failed to establish adequate written procedures for production and process controls designed to assure that the drug products have the identity, strength, purity, and quality that they are purported or represented to possess.
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 →