TMC Acquisitions LLC – FDA 483, Mar 14, 2022

This FDA Form 483 details observations from an inspection, highlighting significant deficiencies in aseptic processing, environmental control, and quality systems.

**Facility and Operations:** The inspection covered sterile injectable drug product manufacturing in ISO 5, ISO 7, and ISO 8 cleanrooms, including compounding of Methylcobalamin, Calcium Chloride, Semaglutide/Cyanocobalamin, and other products.

**Violations and Observations:**

* **Aseptic Manipulations (Observation 1):** Technicians repeatedly interrupted ISO 5 airflow by reaching over open units and having exposed skin (head) inside the ISO 5 hood during sterile product filling. * **Direct Product Contact (Observation 2):** Technicians manually touched the inner surface of sterile stoppers with gloved hands during vial filling for multiple batches, including those distributed to patients. * **Non-Microbial Contamination (Observation 3):** Apparent yellow staining on HEPA filter guard, rust on door trim and under ISO 5 hood benchtop, chipping/cracking walls, rusted box cutter, and residue buildup on countertops, floors, and equipment (wire rack, glass beaker) were observed in cleanrooms. * **Inadequate HEPA Filter Coverage (Observation 4):** Large light panels in ISO 5 hood ceilings broke up HEPA filter coverage, leading to sterile product exposure without adequate HEPA-filtered air. * **Improper