H & P Industries, Inc. – FDA 483, May 18, 2010

The FDA issued a Form 483 to Triad Group on May 18, 2010, following an inspection that revealed significant Current Good Manufacturing Practices (cGMP) violations. The observations spanned multiple areas, highlighting systemic issues in quality control and manufacturing. Key violations included the inadequate validation of sterilization processes for sterile lubricating jelly and alcohol swabsticks. Finished device acceptance procedures were found deficient, with instances of product being distributed before meeting all acceptance criteria and a lack of proper investigation into failed test results. Complaint handling was also a major concern, as the company failed to adequately evaluate and investigate complaints, including those related to product viscosity and adverse events like vaginal irritation, often without filing required Medical Device Reports (MDRs), for which no written procedures existed. Further issues involved a lack of adherence to written production and process control procedures, including failures in corrective and preventive actions (CAPA), pervasive documentation errors, insufficient employee training, unapproved repackaging activities, and inadequate control of quarantined materials. The company also failed to use stability testing results to determine expiration dates and did not follow its stability testing program. Equipment design, maintenance, and cleaning procedures were found to be insufficient, with examples of broken equipment and debris accumulation. Triad Group committed to addressing these deficiencies by revalidating sterilization processes, revising finished product acceptance and complaint handling procedures, developing and implementing MDR procedures, retraining personnel on cGMP and CAPA, improving documentation practices, and upgrading equipment maintenance. Specific timelines were provided for the completion of these corrective actions.