FDA 483 OBSERVATION · #268 OF 1,923 MOST-CITED
Lab controls established, including changes
FDA cited this observation 111 times across 103 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 4.5× the rate of the average FDA-cited firm (34.9% vs 7.8%), across 103 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 establishment of specifications, standards, test procedures and laboratory control mechanisms including any changes thereto, are not drafted by the appropriate organizational unit and reviewed and approved by the quality control unit.
The establishment of laboratory control mechanisms including any changes thereto, are not drafted by the appropriate organizational unit.
The establishment of laboratory control mechanisms including any changes thereto, are not drafted by the appropriate organizational unit and reviewed and approved by the quality control unit.
The establishment of laboratory control mechanisms including any changes thereto, are not drafted by the appropriate organizational unit.
The establishment of specifications, sampling plans, test procedures and laboratory control mechanisms including any changes thereto, are not drafted by the appropriate organizational unit and reviewed and approved by the quality control unit. Electronic records are used, but they do not meet audit trail requirements to ensure that they are trustworthy, reliable and generally equivalent to paper records.
The establishment of laboratory control mechanisms including any changes thereto, are not reviewed and approved by the quality control unit.
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 →