1Computer system validation
You failed to establish procedural controls for your electronic data acquisition systems to ensure that your data records are protected from unauthorized manipulation.
Inspection Record
Fujifilm Diosynth Biotechnologies USA — FDA 483 Findings
View the regulator's official source The source document is always the basis for judgement.
Findings
2Deviation, CAPA, and investigation
Discrepancies are not fully investigated to identify a root cause and corrective and preventative actions (CAPA) are not adequately implemented to prevent recurrence.
3Equipment and facility
Manufacturing areas and equipment in the facility are not adequately designed, maintained, and labeled.
4Material and supplier control
Procedures of material management systems are not followed or are inadequate.
5Equipment and facility
You failed to establish adequate cleaning and sanitization procedures for non-dedicated product contact equipment at this multi product manufacturing facility to prevent cross-contamination.
6Equipment and facility
Microbial control of the facility is inadequate.
7Other quality system
Written procedures are not followed by manufacturing employees.
About this record
Extracted automatically from the document US FDA published on 2021-08-26. The source is available at the link above.
This is a record of that moment. Inspection findings are usually followed by the company's response and corrective action, but this page does not know how that turned out. Do not read it as the current state; check the regulator's official announcements for the latest status.
Translation and classification are automated and may differ in nuance from the source.
