The problem: EM records that don't match what happened
FDA's October 2026 warning letters describe environmental monitoring records that did not match what happened in the lab. Paper logs and loose spreadsheets make it hard to show who sampled and read each plate.
The letters describe unexposed plates logged as sampled and failing results discarded. Those are failures of record-keeping as much as of practice, and they are hard to defend against without an attributable record for every plate.
What this demo shows
- Give each EM plate its own record, with who sampled it and who read it.
- Keep every change in the event log.
- Close an excursion investigation after QA approval.
- See any unread plate on the list.
Why it matters
A result without a clear sampling location and owner leaves questions unanswered. Giving each plate its own record, with who sampled and who read it, makes the history clear.
An event log, QA-approved excursion investigations and a visible list of unread plates give inspectors the evidence that the records match what happened.
See it with your own data
This video is part of Environmental Monitoring. To see how it would work with your own formulations and records, request a demo. Our team replies within 30 minutes during business hours.
Read the transcript
The records showed zero growth apart from one deviation. Plates read during the inspection found about 25 ISO 5 excursions. In that warning letter, FDA found systemic data falsification. Unexposed plates logged as sampled. Cleaning logged but not done. Another letter describes failing environmental samples mistakenly discarded and a sterility failure invalidated without adequate scientific justification.
Both letters ask for attributable contemporaneous records. In Uncountable, where lab data is structured, each plate gets its own record. The event log keeps every change, who, when, and the old and new value. An excursion gets a phased investigation with QA approval before it closes. And an unread plate stays on the list with no count, so the gap shows.
If a failing plate disappeared from your lab today, would your records show it?
