FDA EIR - Chattem Chemicals, Inc. - July 19, 2018

Chattem Chemicals, Inc. underwent a "for cause" FDA inspection between July 10 and July 19, 2018. Conducted under the Active Pharmaceutical Ingredient (API) Process Inspections regulatory framework (C.P. 7356.002F), the inspection encompassed the company's Quality, Facilities/Equipment, Production, Materials, and Laboratory systems.

The inspection resulted in an FDA-483, Inspectional Observations, highlighting four main issues. Firstly, cleaning procedures for drug substances intended for parenteral use, specifically Glycine and Fentanyl Citrate, had not been adequately validated to address microbiological and pyrogen contamination. Secondly, cleaning procedures for water-insoluble drug substances were found to be ineffective, as indicated by recurring cleaning verification failures for products such as Methylphenidate base and Butalbital without proper resolution. Thirdly, the company lacked established control mechanisms for critical laboratory equipment and instruments, including the absence of temperature monitoring for a refrigerator storing reference standards and reagents, and for an instrument room. Lastly, production equipment cleanliness status was not consistently identified, and certain equipment, like transfer hoses, was not properly stored.

In response to these findings, Chattem Chemicals, Inc. initiated immediate corrections where feasible and committed to implementing further corrective actions. Management also provided assurance that a comprehensive written response addressing all FDA-483 observations would be submitted.