FDA 483 - Immunomedics, Inc. - March 10, 2020

On March 10, 2020, the FDA issued a Form 483 to Immunomedics, Inc., a drug substance intermediate manufacturer located in Morris Plains, NJ, following an inspection from March 2-10, 2020. The inspection revealed ten observations related to quality system and manufacturing deficiencies.

Key observations include: 1. **Microbiological Contamination Control:** Procedures and controls to prevent microbiological contamination of drug substance intermediates are not established. This includes a lack of procedures, gowning requirements, and QA review for dynamic smoke studies in ISO 5 Biological Safety Cabinets (BSCs), with studies not simulating worst-case conditions. Additionally, a filter used for sterilization is not routinely sterilized or integrity tested, and the water used for sterilization is not routinely tested for critical physical qualities. 2. **Quality Control Unit Responsibilities:** The responsibilities and procedures of the quality control unit are not fully followed. Final QA and microbiology review and approval for operations were not performed in a timely manner, leading to conditional approvals and ongoing production without complete release. Bare hands, bare forearms, and street clothes were observed within a BSC during dynamic smoke studies, and associated medium bottles were subsequently used without QA or microbiology evaluation. Chromatograms are not electronically or manually indicated for quality unit review. 3. **Inadequate/Unfollowed SOPs:** Standard Operating Procedures (SOPs) are inadequate or not followed. Examples include: