First citz are unapproved drugs? Jeez
What have you done today to make you feel proud..."Upon receiving a consumer complaint regarding the potential presence of lead in two batches of (b)(4) mg/mL, (b)(4)-ounce (b)(4), your subsequent investigation focused solely on one of the two batches. Notably, a third batch, utilizing the same (b)(4) component as one of the complaint batches, was not included as part of your investigation. Additionally, your firm stated during our inspection that no testing was conducted to investigate whether lead was present."
To ensure QC, the entire executive team should be used to sample the products off the manufacturing line (before they're sent to India).Do they think we can’t look up the FDA warning letter and read it? “Pausing” production? That doesn’t happen when it’s “no big deal”.