483
Valley BiosystemsFDA 483 - Valley Biosystems - October 08, 2021
Discuss this record with AI
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.
Record Details
Valley Biosystems received a Form 483 citing 10 observations related to Good Laboratory Practice (GLP) deficiencies. Key issues include the study director's lack of overall responsibility and protocol adherence, inadequate data recording and retention, and failures in quality assurance, training, and equipment calibration. The report highlights significant concerns regarding data integrity and the proper conduct of nonclinical laboratory studies.
Open in Dashboard
ID · 12f2cad5-2164-4023-b487-1ba2810c6b7d