FDA issues Form 483s to Japanese, Indian drugmakers in wake of plant inspections

Two Japanese drugmakers and another in India were hit with Form 483s from the FDA following inspections that uncovered issues ranging from a lack of sanitary procedures to improper data collection and monitoring. The manufacturers in Japan, Otsuka Pharmaceutical and Taenaka Kogyo, received their Form 483s in the spring. The FDA posted the documents on its website in recent days.

Otsuka’s production facility in Tokushima, Japan, which was inspected March 13-22, was cited with five observations. The agency’s inspectors flagged the company’s failure to keep certain equipment clean and sanitized to prevent contamination, plus the plant’s lack of monitoring of environmental conditions in aseptic processing areas, among other observations. Equipment was “not adequately cleaned at appropriate intervals to prevent cross-contamination from drug substances previously manufactured,” the agency said in the filing. Taenaka Kogyo, an API maker, was hit with four observations after an inspection at its Mobara facility that ran from April 8-12.

During the inspection, the FDA found a lack of proper training for employees regarding good manufacturing procedures. Inspectors also took issue with Taenaka Kogyo’s ventilation systems not being designed to minimize contamination, plus the firm’s improper monitoring of materials and failure to ensure that API specifications are met.

Biocon Biologics’ facility in Bengaluru, India, was cited with 10 observations, with the most severe being the site’s lack of established procedures—or failure to follow procedures—to prevent contamination. The inspection was conducted between July 15-19 and July 22-26. The facility was also cited for not following or establishing laboratory test procedures, lacking computerized systems and controls over production data, failing to investigate unexplained discrepancies and not maintaining equipment.