Fill It Pack It Inc – FDA Warning Letter, Nov 5, 2018

The FDA inspected Fill It Pack It Inc. from October 26 to November 5, 2018, identifying significant CGMP violations for finished pharmaceuticals, rendering their drug products adulterated. The firm failed to establish and follow appropriate written procedures to prevent microbiological contamination of sterile drug products, including validation of aseptic and sterilization processes (21 CFR 211.113(b), 211.42(c)(10)). Their filling suite was unsuitable for sterile drug filling, lacking proper surfaces, HEPA-filtered air, environmental monitoring, and cleaning/disinfection systems. Bulk drug product was held for seven weeks and used without sterilization.

The firm also failed to establish an adequate Quality Control Unit (QU) with authority to approve/reject materials and products (21 CFR 211.22(a), (d)), a repeat violation. The QU released ophthalmic drug product without ensuring sterility, and containers/closures were not sterilized. FDA lab analysis confirmed ophthalmic drug product samples were contaminated with Bacillus spp. and/or high levels of particulate matter, leading to a recall by the product owner.

The firm's November 23, 2018, response was inadequate, lacking supporting documentation for corrective actions, a plan to determine which drugs require sterility, and a process to screen future drug products. The FDA requires detailed CAPA documentation, including bulk hold times, cleaning validation, screening criteria, and