483
Biovectra, Inc.Biovectra, Inc. – FDA 483, Feb 17, 2017
Record Details
An FDA inspection of BioVectra Inc. in Charlottetown, PE, Canada, identified a significant issue with the firm's stability program. The company consistently failed to complete stability testing in a timely manner for several batches of Bulk API. This indicates a failure to follow their own standard operating procedures for administering a stability program.
View Company Profile
ID · 3bf401c7-eb39-461b-8c0f-cdd5e373fe9b
Other documents for Biovectra, Inc.
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.