FDA 483 - IntegraDose Compounding Services LLC - March 01, 2024

From February 12 to March 1, 2024, the FDA inspected IntegraDose Compounding Services LLC, an outsourcing facility in Minneapolis, MN, led by Craig E. Else, Director and COO. The inspection revealed eight observations related to quality systems and production controls.

**Quality System Deficiencies:** * **Inadequate Investigations:** The firm failed to thoroughly investigate unexplained discrepancies and batch failures. This includes invalidating a positive sterility test for Cefazolin without a root cause, releasing Cefazolin batches despite 65 leaking syringes without investigation, and lacking investigations into personnel monitoring growth (e.g., spore-forming bacteria on technician forearms) and leaking Fentanyl Citrate CADDs. Over 30 incidents of leaking cefazolin bags were documented without investigation. White particulate matter on Cefazolin syringes was observed without root cause identification. Furthermore, an investigation into leaking Hydromorphone HCl and Fentanyl Citrate CADD samples lacked root cause analysis for overfilling, and no formal retraining or procedure for shipping damage was implemented. * **Lack of Process Validation:** The firm has not performed process validation for numerous drug products, including various Cefazolin, Phenylephrine Sulfate, Oxytocin, Vasopressin, and Fentanyl Citrate/Ropivacaine HCl formulations. A current recall (D-0258-2024) for sub-potent Vasopressin batches, linked to a