FDA EIR - Gaylord Chemical Company, LLC - February 26, 2018

A surveillance cGMP inspection of Gaylord Chemical Company, LLC, a human/animal Active Pharmaceutical Ingredient (API) manufacturer in Tuscaloosa, AL, was conducted by the FDA from February 21-26, 2018. The inspection, guided by CP 7356.002F, CP 7371.001, and ICH Q7, identified several significant issues despite no FDA 483 being issued due to the company's existing action plans and commitment to corrections. Main observations included a lack of data integrity controls for electronic systems used for cGMP purposes, and numerous Standard Operating Procedures (SOPs) lacking crucial information or details. Furthermore, the contract packager for bottle packaging operations exhibited significant deficiencies, such as out-of-tolerance equipment calibrations and absent cleaning validation, with no response or commitment to correction from the packager. This was particularly concerning as the non-sterile API packaged is used in sterile, injectable drug products, yet the packager lacked bioburden controls. Other issues noted insufficient calibration and maintenance details in process re-validation and the storage of USP-grade Dimethyl Sulfoxide without adequate temperature controls. Gaylord Chemical Company management provided a written commitment letter outlining estimated timeframes to address all verbal observations, including plans for Part 11 compliance for electronic systems, comprehensive SOP updates, an addendum for validation data, and an evaluation of storage conditions for DMSO.