FDA EIR - H & P Industries, Inc. - April 19, 2010

H & P Industries, Inc., operating as Triad Group, underwent an FDA inspection from April 19 to May 18, 2010, at its Hartland, WI facility. This routine inspection, guided by drug manufacturing and medical device compliance programs, identified a significant number of ongoing and new Current Good Manufacturing Practice (cGMP) deficiencies, leading to a 23-item FDA-483. Ten of these items were repeat violations or indicated inadequate corrective actions from a prior 2009 inspection. Key issues included a lack of validated sterilization processes for sterile lubricating jelly medical devices and alcohol swabstick drug products, with evidence of microbial growth in post-sterilization lubricating jelly samples. The firm shipped products that failed quality specifications, such as low-viscosity lubricating jelly and alcohol prep pads with incorrect active ingredient assay, often without proper investigation or rejection. Numerous procedural failures were noted, including inadequate complaint investigations, shipping products before final release testing, and a lack of proper documentation and employee training. Additionally, several sterile alcohol products were identified as unapproved new drugs under 21 CFR 310.502 due to their sterilization method. The company also faced unsanitary manufacturing conditions and concerns about metal contamination in infant suppositories, which was initially slated for recall but later deferred. Management committed to providing a written response to the FDA-483 observations.