Findings
1Deviation, CAPA, and investigation
The scope of the investigation included four failed stability intervals for batch (b)(4) (e.g., (b)(4) ) and two failures for batch (b)(4) (e.g., (b)(4) and (b)(4) ). Although the Phase I investigation did not identify any discrepancies in test performance, it does not specify which of the collective six failed timepoints was the subject of the laboratory observation. Retains for the final timepoints for each batch were retested confirming the initial failure but retains…
2Quality unit oversight
Your firm’s quality control unit failed to exercise its responsibility to ensure drug products manufactured are in compliance with CGMP, and meet established specifications for identity, strength, quality, and purity (21 CFR 211.22). A. Your quality unit (QU) failed to adequately document and investigate multiple out-of-specification (OOS) results. Specifically, our inspection found that: Bulk Intermediate lot (b)(4) , Xerac AC, failed the active ingredient content (Aluminum…
3Process validation
Your firm failed to establish adequate written procedures for production and process control designed to assure that the drug products you manufacture have the identity, strength, quality, and purity they purport or are represented to possess (21 CFR 211.100(a)). Changes to the formulations of OTC drug products DHS Tar Shampoo and DHS Zinc Shampoo, including the introduction of different inactive ingredients, were made without demonstrating you have a reproducible commercial…
4Deviation, CAPA, and investigation
Your firm failed to thoroughly investigate any unexplained discrepancy or failure of a batch or any of its components to meet any of its specifications, whether or not the batch has already been distributed (21 CFR 211.192). Three over the counter (OTC) drug products: Solbar Zinc Sunscreen, DHS Zinc Shampoo, and DHS Tar Shampoo failed to meet pre-defined quality attributes at multiple timepoints during long-term room temperature storage conditions. A timely and thorough investigation into the root causes of the OOS events was not performed. Multiple high pH failures in Solbar Zinc Sunscreen long-term stability studies were investigated in OOS No.
About this record
Extracted automatically from the document US FDA published on 2025-09-30. The source is available at the link above.
This is a record of that moment. Inspection findings are usually followed by the company's response and corrective action, but this page does not know how that turned out. Do not read it as the current state; check the regulator's official announcements for the latest status.
Translation and classification are automated and may differ in nuance from the source.
