FDA WARNING_LETTER - Texas Applied Biomedical Services - April 25, 2012

This FDA Warning Letter to Texas Applied Biomedical Services (TABS RRC) details significant violations of federal regulations (21 CFR Parts 50 and 56) following an inspection concluding April 25, 2012.

Key violations include: 1. **Conflict of Interest (21 CFR § 56.107(e)):** The Chairperson and another member participated in reviewing and approving studies for a sponsor they provided consulting services to, despite TABS RRC's own procedures prohibiting such involvement. 2. **Failure to Follow Written Procedures (21 CFR §§ 56.108(a), 56.115(a)(6)):** The IRB lacked written procedures for reviewing protocols involving children, despite approving a pediatric study. 3. **Inadequate Membership Competence (21 CFR § 56.107):** The IRB lacked necessary professional competence (e.g., a physician) to review studies involving specific medical conditions (e.g., (b)(4) disorders, (b)(4)) and failed to document external consultations. 4. **Failure to Comply with Pediatric Safeguards (21 CFR §§ 56.109(h), 56.111(c)):** The IRB did not document its determination of risk level, potential benefit, or adequate provisions for child assent for a pediatric study.