FDA EIR - Ajinomoto Althea, Inc. - May 18, 2015

The FDA conducted a Pre-Approval and Current Good Manufacturing Practice (cGMP) inspection of Ajinomoto Althea, Inc., a contract manufacturer of sterile drug products in San Diego, CA, from May 6 to May 18, 2015. The inspection covered specific drug product applications, (b)(4) and (b)(4), for which the company performs fill/finish and some release testing. This inspection followed established FDA guidelines for biological therapeutic drug products and pre-approval inspections. At the conclusion of the inspection, a two-item FDA-483 was issued, detailing cGMP deficiencies. The primary violations included the practice of transferring formulated bulk drug product from classified cleanroom environments to unclassified refrigerated storage and back into the cleanroom for filling without implementing an additional filtration step. A second observation pertained to the inadequate material qualification of specific manufacturing bags ((b)(4) bags). Company management acknowledged the deficiencies and immediately began corrective actions during the inspection. They committed to submitting a formal written response to the FDA-483 within 15 days. Additionally, several operational discussion points were communicated, including the need for media fills to accurately reflect production processes, consistent review of cleanroom pressure differential data, and timely closure of Out-of-Tolerance investigations, to which management also promised corrections.