FDA 483 OBSERVATION · #736 OF 1,932 MOST-CITED
Adequate and readily accessible
FDA cited this observation 28 times across 27 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
Adequate washroom facilities for use of employees are not readily accessible adjacent to where land and air conveyances are maintained.
Adequate essential sanitary facilities for use of employees are not readily accessible adjacent to areas where air conveyances are serviced.
Adequate essential sanitary facilities for use of employees are not readily accessible adjacent to areas where air conveyances are serviced and maintained.
Adequate washroom facilities for use of employees are not readily accessible adjacent to areas where land conveyances are serviced.
Adequate essential sanitary facilities for use of employees are not readily accessible adjacent to places and areas where air conveyances are serviced, maintained and cleaned.
Adequate washroom and essential sanitary facilities for use of employees are not readily accessible adjacent to areas where air conveyances are serviced.
Examples are a representative sample of FDA's published inspection observations. Open the 483 observation explorer →