The FDA faulted API manufacturer Otsuka Pharmaceutical over its cleaning procedures and its maintenance of facilities and equipment.
The agency issued a Form 483 following an April 2016 inspection of Otsuka’s Yoshinogari facility in Japan. Inspectors found that the facility did not establish clean hold times for all of its non-dedicated manufacturing equipment. The agency also found Otsuka’s investigations into unexpected discrepancies were not thorough. In some cases, the company invalidated initial test results and reported only retest data without justification.
The facility also failed to assign appropriate user access levels for its information management and data acquisition systems and it lacked adequate maintenance of sampling rooms. The agency observed numerous deficiencies in one sampling room, including a dust collector that failed a filter leak test.
In addition, the facility did not properly maintain its laboratory equipment. A quality control manager told FDA officials a device used to clean dirty pipettes had not been calibrated or undergone any preventive maintenance since its initial qualification in 2014.