IBA Molecular, Inc – FDA Warning Letter, May 27, 2009

The FDA inspected IBA Molecular, Inc.'s Sterling, Virginia facility from May 12-27, 2009, uncovering significant deviations from USP compounding standards and official monographs for PET drugs in the manufacturing of [(b)(4)] for injection. These issues render the drug products adulterated under Section 501(a)(2)(C) of the Federal Food, Drug, and Cosmetic Act. Additionally, the firm failed to register as a drug establishment as required by Section 510. Deficiencies were noted across Quality Control, Production, Laboratory, Facilities, and Equipment systems. Specific violations included failure to establish appropriate analytical procedures, conducting incomplete endotoxin tests, invalidly retesting out-of-specification sterility results, and inadequate sterilization activities. The firm also failed to investigate unplanned deviations and OOS results, and aseptic manipulations were not performed with appropriate technique or gowning. Equipment maintenance was not verified, and the Quality Control Unit was found to be inadequate in its oversight. Furthermore, a proposed SOP for sterility testing was deemed unacceptable for allowing automatic retests without proper evaluation and extending the test start time beyond compendial expectations. The FDA requires prompt, comprehensive corrective actions, including evaluating the impact of past deficiencies on patient safety, revising procedures, ensuring proper investigations, enhancing sterility control, and addressing QCU failures, with specific timelines. Failure to correct these violations may lead to legal action, injunctions, and impact on contracts, export certificates, and drug approvals.