Telix IsoTherapeutics Group, Inc. – FDA 483, May 17, 2019

An FDA inspection of Isotherapeutics Group LLC in Angleton, TX, revealed significant deficiencies in current Good Manufacturing Practices for drug products. The firm was cited for inadequate cleanroom design and maintenance, insufficient equipment cleaning and sanitization procedures, and failures in their quality control unit. These issues included a lack of written procedures for production records, complaint handling, and labeling, indicating a lack of control over critical manufacturing processes.