FDA 483 OBSERVATION · #765 OF 1,932 MOST-CITED
SOPs for investigations, records
FDA cited this observation 26 times across 26 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
Written standard operating procedures for all steps in the investigation of product deviations under the regulations and recordkeeping related to current good manufacturing practice and other applicable requirements and standards were not established, maintained, followed and available to personnel in the areas where procedures were performed.
Written standard operating procedures for all steps in the investigation of product deviations under the regulations and recordkeeping related to current good manufacturing practice and other applicable requirements and standards were not established, maintained and followed.
Written standard operating procedures for all steps in recordkeeping related to current good manufacturing practice and other applicable requirements and standards were not followed.
Written standard operating procedures for all steps in the investigation of product deviations under the regulations were not established.
Written standard operating procedures for all steps in the investigation of product deviations under the regulations were not established, maintained and followed.
Written standard operating procedures for all steps in the investigation of product deviations under the regulations were not followed.
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 →