FDA 483 - Erin K. Coello, DVM - August 01, 2025
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.
Coello Veterinary Services in Jacksonville, FL, a clinical investigator, was cited for significant issues compromising the validity and integrity of study data during an inspection. Observations included failures to perform required subject counts, non-contemporaneous data entry, discarding of source documentation, errors in dispensing investigational veterinary products, and untimely reporting of adverse events to the sponsor. These findings indicate serious deficiencies in the conduct and oversight of clinical investigations.
ID · 02275bef-a662-432b-a70f-e87b6f5dfb70