FDA EIR - Matthew Teltser MD - January 31, 2020

An FDA inspection of Matthew Teltser, M.D., located in Pembroke Pines, FL, was conducted from January 23 to January 31, 2020. This "for cause" inspection, initiated due to a complaint of data fabrication and limited oversight, focused on two Phase III asthma clinical trials (Protocols AV004 and AV003) sponsored by Bond Avillion 2 Development LP. The inspection followed the regulatory framework for Bioresearch Monitoring of Clinical Investigators (Compliance Program 7348.811).

While allegations of data fabrication could not be definitively confirmed, the inspection identified several protocol deviations. A primary concern was Dr. Teltser's failure to conduct the investigation according to the protocol. Specific issues included one subject in Protocol AV004 being enrolled and randomized before the central pulmonary function test results were reviewed by the investigator. Furthermore, several subjects in both studies were enrolled without adequate medical records, such as documentation not signed by a physician or insufficient evidence of stable inhaled corticosteroid use as required by the protocols. The inspection also noted alarming similarities, including identical language and misspellings, across medical records for different subjects, raising concerns about data integrity.

No FDA Form 483 (Inspectional Observations) was issued, but verbal observations were discussed. Dr. Teltser acknowledged these issues and committed to implementing required actions, including reviewing all records before subject randomization, obtaining written sponsor permission for protocol deviations, and ensuring complete documentation of inclusion criteria and diary compliance. The Agency informed Dr. Teltser that these observations could lead to administrative actions, injunctions, fines, or prosecution upon further review.