US FDA Training and personnel findings

Employees engaged in the manufacture and processing of a drug product lack the training and experience required to perform their assigned functions.

There is an inadequate number of personnel to manufacture and test APIs adequately.

Personnel were observed moving quickly in a critical area or in an area immediately adjacent to a critical area likely causing disruption of unidirectional airflow.

Production personnel were not practicing good sanitation and health habits.

Employees are not given training in the particular operations they perform as part of their function and current good manufacturing practices.

Employees engaged in the manufacture, processing, packing and holding of a drug product lack the training required to perform their assigned functions.