FDA WARNING_LETTER - SOFIE Co. dba SOFIE - April 12, 2019

The FDA inspected Sofie Co., d.b.a. SOFIE, at 136 Commerce Way, Sanford, Florida, from April 3 to 12, 2019, identifying significant violations of current good manufacturing practice (CGMP) regulations for positron emission tomography (PET) drugs, rendering their products adulterated under 21 U.S.C. 351(a)(2)(B). Key violations included inadequate facilities to prevent contamination (21 CFR 212.30(a)), evidenced by persistent fungal contamination (e.g., Penicillium decumbens) in ISO 5 areas and operator gloves from September 2018 to March 2019. The firm continued PET drug production without adequate interim measures despite this contamination and failed to thoroughly assess the scope and routes of fungal entry into ISO 5 areas. The FDA noted that similar CGMP violations were cited at another SOFIE facility, indicating inadequate management oversight. The company's May 3, 2019, response was deemed inadequate. Sofie Co. is required to provide a comprehensive risk assessment of contamination hazards, a detailed remediation plan with timelines, action levels for classified areas, and a list of all out-of-limit environmental monitoring results since April 1, 2019. A written response is required within 15 working days, detailing corrective actions and a schedule for completion. Failure to promptly correct violations may result in legal action, including seizure and injunction, and may impact federal contracts and drug approvals.