Professional Disposables International, Inc. – FDA 483, Oct 21, 2010

During an inspection conducted from October 14 to October 21, 2010, the U.S. Food and Drug Administration (FDA) issued a Form 483 to Professional Disposables International, Inc., a pharmaceutical drug manufacturer located in Orangeburg, NY. The inspection identified significant deviations from Current Good Manufacturing Practice (CGMP) regulations. The primary observation noted a repeated failure to thoroughly investigate unexplained discrepancies and batches that did not meet specifications. The firm’s investigations were deemed inadequate, often lacking comprehensive explanations, impact assessments on product quality, root cause analyses, and appropriate corrective or preventive actions. This included numerous instances where product lots, such as Sani Hands ALC and PDI BZK Twilt, contained unacceptably low levels of active ingredients like Ethyl Alcohol or Benzalkonium Chloride. Notably, this issue was a repeat observation from a previous inspection in 2008. Further observations included the failure to adhere to written production and process control procedures. An example cited involved using an incorrect liquid during the manufacturing of PDI PVP Duo Swabs due to an oversight in checking drum labels, contrary to established standard operating procedures. Additionally, the inspection found that the company lacked established and followed procedures for the warehousing of drug products. Professional Disposables International, Inc. is required to promptly address these observations by implementing comprehensive corrective and preventive actions to ensure compliance with federal regulations and prevent recurrence of these issues.