483
Biospace Inc.FDA 483 - Biospace Inc. - April 22, 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 Biospace Inc., a medical device manufacturer in Los Angeles, CA, revealed two significant observations. The firm failed to document acceptance activities, specifically quality inspections of received devices. Additionally, Biospace Inc. had not established its own procedures for corrective and preventive actions (CAPA).
Open in Dashboard
ID · d519fbdd-3c68-4921-b0c1-ceb88fb891e1