FDA 483 - Consumer Product Partners, LLC - July 23, 2021

Vi-Jon Inc., a drug manufacturer in Smyrna, TN, received an FDA Form 483 citing two significant observations. The firm failed to thoroughly investigate unexplained discrepancies, specifically the presence of foreign/particulate matter in products, which was noted as a repeat observation. Additionally, the inspection revealed inadequate controls over computer systems used in analytical instruments, with multiple unauthorized employees possessing administrative rights.