FDA EIR - Knowlton Development Company dba Thibiant International Inc. - May 25, 2018

An FDA surveillance inspection of Knowlton Development Company dba Thibiant International, Inc., a contract manufacturer of OTC topical drug products, was conducted from May 21-25, 2018. The inspection, performed under the Drug Manufacturing Inspections program, focused on the company’s Quality, Facilities and Equipment, Materials, and Laboratory systems. The regulatory framework for this inspection was CPGM 7356.002, Drug Manufacturing Inspections.

The inspection identified eight significant observations of non-compliance. Key issues included an inadequate quality control unit and a lack of required training for employees involved in drug product manufacturing. Furthermore, the company failed to establish appropriate control procedures for manufacturing processes, lacked written production and process control procedures to ensure product quality, and did not maintain scientifically sound laboratory controls and complete test records. Deficiencies were also noted in the drafting of laboratory control mechanisms and adherence to written production procedures.

Six additional concerns were discussed with management, such as insufficient control over facility and equipment changes, absence of an annual retained sample inspection policy, and inadequate analytical instrument logbook reviews. A critical issue was the lack of a comprehensive quality agreement with a key customer outlining shared responsibilities for contract manufacturing and Good Manufacturing Practices.

Management, represented by Mr. Dale A. Dvorak, committed to addressing all observations and discussed items, with a written response promised within 15 business days. The firm was cautioned about potential legal and advisory sanctions for observed violations.