US Pharmaceuticals Inc. – FDA Warning Letter, Dec 18, 2018

The FDA issued a Warning Letter to US Pharmaceuticals, Inc. following an inspection from October 31 to December 18, 2018, at their Belleville, New Jersey drug manufacturing facility. The inspection revealed significant violations of current good manufacturing practice (CGMP) regulations (21 CFR, parts 210 and 211), rendering their drug products adulterated.

Key violations include: 1. **Failure to thoroughly investigate discrepancies (21 CFR 211.192):** The firm frequently lacked investigations into failing microbiological and chemical results from their purified water system, including high microbial counts (TNTC) and exceeding total organic carbon (TOC) limits. These water lots were used in OTC drug products. The company's response was deemed inadequate for not addressing investigation procedures (SOP-016, SOP-017) and failing to ensure thorough, timely investigations with root cause analysis and CAPA. The FDA noted that finished product microbial testing alone is insufficient for release. The company initiated partial recalls but lacked rationale for products remaining on the market. 2. **Inadequate equipment design (21 CFR 211.63):** The purified water system was not adequately designed, controlled, or maintained to consistently produce water meeting USP specifications. Design issues contributing to biofilm and bacterial growth, identified in 2016, were not addressed. A proposed sanitation schedule was deemed insufficient as