FDA 483 - Laboratoires KABS Inc. - July 25, 2024

An FDA inspection of Laboratoires KABS Inc., a human drug and medical device manufacturer, was conducted from January 22-25, 2024, resulting in three significant observations documented on Form FDA 483. For human drug manufacturing, the firm was cited for not having written responsibilities and procedures for its quality control unit. Specifically, the cleaning process qualification protocol for a filling machine was deficient, lacking detailed swab sampling locations, omitting microbiological testing, and failing to sample primary packaging containers. In medical device manufacturing, two issues were identified. Firstly, a critical assembly machine process was not adequately validated; the company failed to document acceptable setting ranges and actual settings used during the machine's operational and performance qualifications. Secondly, procedures for corrective and preventive actions (CAPA) were inadequate, as the effectiveness of corrective actions for four reviewed CAPA records was not sufficiently verified or documented. These observations highlight deviations from regulatory expectations, requiring Laboratoires KABS Inc. to develop and implement comprehensive corrective actions, particularly for observations two and three which were noted as 'Promised to correct' during the inspection.