FDA 483 OBSERVATION · #879 OF 1,932 MOST-CITED
Prevention of unsafe contamination by equipment
FDA cited this observation 21 times across 20 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.
How FDA worded it — real examples
You did not use physical means, flushing and sequential production of feeds to prevent unsafe contamination of manufactured feed.
You did not use flushing and sequential production of feeds to prevent unsafe contamination of manufactured feed.
You did not use flushing and sequential production of feeds to prevent unsafe contamination of manufactured feed.
All equipment that comes in contact with active drug components and finished medicated feed is not subject to all reasonable and effective procedures to prevent unsafe contamination of manufactured feed.
All equipment that comes in contact with feeds in process and finished medicated feed is not subject to all reasonable and effective procedures to prevent unsafe contamination of manufactured feed.
All equipment that comes in contact with active drug components, feeds in process and finished medicated feed is not subject to all reasonable and effective procedures to prevent unsafe contamination of manufactured feed.
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 →