FDA 483 - Erin K. Coello, DVM - August 01, 2025

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.