FDA WARNING_LETTER - Brar, Saroj M.D. - May 18, 2007

On April 24-May 18, 2007, the FDA inspected Dr. Saroj Brar's conduct of two clinical investigations: Protocol [redacted] (Paliperidone Palmitate) and Protocol [redacted] ([redacted] for manic/mixed episodes). The inspection, part of the Bioresearch Monitoring Program, found Dr. Brar failed to adhere to statutory requirements and FDA regulations for clinical investigations and human subject protection.

Key violations include: 1. **Failure to obtain informed consent:** A guardian signed for one subject, and another subject consented while delusional, violating 21 CFR § 312.60 and 21 CFR § 50.20. 2. **Failure to protect subject rights, safety, and welfare:** One subject received an extra dose of study medication with no documented follow-up for side effects. An adverse event (exacerbation of paranoid schizophrenia) was not reported to the IRB until over two months later, violating 21 CFR § 312.60. 3. **Failure to conduct studies according to investigational plans:** Subjects received lorazepam doses exceeding protocol limits, lithium treatment duration was insufficient, and study medication administration schedules were not followed, violating 21 CFR § 312.60. 4. **Failure to maintain adequate and accurate case histories:** Discrepancies in study medication