FDA 483 - Wisconsin Medical Radiopharmacy, LLC.

Wisconsin Medical Radiopharmaceuticals, LLC in Wauwatosa, WI, received a Form 483 following an inspection that identified significant deficiencies. The firm was cited for inadequate process and production controls for PET drug manufacturing, including issues with hold time studies, manufacturing process controls, and radiochemical purity testing. Additionally, observations noted insufficient record storage, lack of equipment cleaning validations, and inadequate quality assurance procedures.