FDA 483 OBSERVATION · #254 OF 1,923 MOST-CITED
Quality control - processes, specifications, written procedures
FDA cited this observation 119 times across 108 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 is associated with
Firms cited for this observation also appear in FDA compliance actions — warning letters, injunctions, or seizures — at 4.7× the rate of the average FDA-cited firm (36.1% vs 7.8%), across 108 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 quality control personnel did not approve or reject processes, specifications, written procedures and controls that may affect the identity, purity, strength, or composition of a dietary supplement.
Your quality control personnel did not approve or reject written procedures that may affect the identity, purity, strength, or composition of a dietary supplement.
Your quality control personnel did not approve or reject written procedures, tests and examinations that may affect the identity, purity, strength, or composition of a dietary supplement.
Your quality control personnel did not approve or reject processes and written procedures that may affect the identity, purity, strength, or composition of a dietary supplement.
Your quality control personnel did not approve or reject specifications that may affect the identity, purity, strength, or composition of a dietary supplement.
Your quality control personnel did not approve or reject processes, controls and deviations or modifications that may affect the identity, purity, strength, or composition of a dietary supplement.
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 →