483
PharmaLegacy Research LLCFDA 483 - PharmaLegacy Research LLC - June 21, 2019
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
An FDA inspection of Samm Solutions, Inc. (dba BTS Research) in San Diego, CA, a non-clinical laboratory, revealed significant deficiencies across multiple studies. The firm failed to adhere to study protocols, properly archive raw data, document and authorize deviations, and ensure the accuracy of experimental data. These issues indicate a systemic lack of control and oversight in their GLP-regulated non-clinical laboratory studies.
Open in Dashboard
ID · 458d960c-5b8e-4be8-bbb9-6d1ae8af6ffe