FDA WARNING_LETTER - Smitha C. Reddy, M.D./ACRC Studies, LLC - August 20, 2021

This FDA Warning Letter, dated June 14, 2022, addresses objectionable conditions observed during an inspection of Dr. Reddy's clinical site from August 4 to August 20, 2021, as part of the Bioresearch Monitoring Program. The inspection reviewed the conduct of clinical investigations for Protocols (b)(4), (b)(4), and (b)(4).

The letter states that Dr. Reddy failed to ensure the investigation was conducted according to the investigational plan, violating 21 CFR 312.60. Specific violations include: 1. **Protocol (b)(4) - Incorrect Drug Administration:** Subject (b)(6) was incorrectly administered active investigational drug (b)(4) instead of the assigned (b)(6) at Study Visit Weeks 2, 3, and 4. This raises concerns about data reliability and subject safety. 2. **Protocol (b)(4) - Unblinding of Independent Assessor:** Subinvestigator (b)(4), designated as an independent (b)(4) assessor, also reviewed (b)(4) for Subject (b)(6), compromising the blinding requirement to reduce bias. This raises concerns about data integrity. 3. **Protocol (b)(4) - Unblinded Assessor Performing Blinded Tasks:** Dr. Reddy, an unblinded study personnel, performed qualitative endpoint assessments (b)(4)