FDA WARNING_LETTER - PETNET Solutions Inc - April 05, 2019

The FDA inspected PETNET Solutions Inc.'s drug manufacturing facility in Woburn, Massachusetts, from March 19 to April 5, 2019, identifying significant violations of current good manufacturing practice (CGMP) regulations for positron emission tomography (PET) drugs (21 CFR part 212). Consequently, the firm's PET drug products are deemed adulterated. Key violations include inadequate facilities to prevent contamination (21 CFR 212.30(a)), evidenced by disrepair, lack of cleanliness, and adverse trends in environmental and personnel monitoring, including sporeforming organisms and a sterility test failure. The firm also failed to develop and follow adequate written procedures for testing (21 CFR 212.60(a) and (b)), specifically concerning inappropriate environmental monitoring action levels and operator errors during sterility testing. The FDA noted the firm's inadequate response to microbial control data and recommended engaging a CGMP consultant. The company must provide comprehensive risk assessments, monitoring results, and detailed plans for facility remediation and laboratory system improvements. A written response detailing corrective actions is required within 15 working days, with a regulatory meeting to be scheduled within five days. Failure to promptly correct these violations may result in legal action, including seizure and injunction, and impact federal contracts, export certificates, and drug application approvals.