FDA EIR - H & P Industries, Inc. - May 18, 2010

The FDA conducted a follow-up inspection of H & P Industries, Inc. dba Triad Group between April 19 and May 18, 2010, revealing significant Current Good Manufacturing Practice (cGMP) deficiencies for its Over-the-Counter (OTC) drug and medical device operations. The inspection resulted in a 23-item FDA-483, with 10 observations being repeat findings or indicating inadequate corrective actions from a prior inspection. Major issues included the absence of validated sterilization processes for sterile lubricating jelly and alcohol products, leading to microbial contamination, including Staphylococcus aureus, and inadequate finished product testing procedures. The firm shipped products that failed specifications, such as viscosity for lubricating jelly and active ingredient assay for prep pads, without proper investigation or rejection. Other violations encompassed a lack of written and followed quality control procedures, insufficient investigations into failed batches, poor employee training, and manufacturing products considered unapproved new drugs under 21 CFR 310.502 due to sterilization methods. A planned recall of Infant Glycerin Suppositories due to metal contamination was deferred. The company is required to take comprehensive corrective actions to address these critical non-compliance issues, particularly validating sterilization processes, enhancing quality control, and ensuring product safety and conformity.