Japanese Drugmaker Rapped for Cleaning Violations
The FDA hit API drugmaker Alps Pharmaceutical of Gifu, Japan with a Form 483 for contamination, inadequate written procedures for cleaning and other violations.
An agency inspection revealed the firm didn’t properly clean equipment and utensils to prevent contamination or material carry-over. White residues were observed in the facility in areas that would alter API quality beyond specifications — including in a tank that had been marked as “cleaned.”
The agency also noted that the firm’s written procedures for cleaning and maintenance did not sufficiently describe how to prepare a cleaning solution or specify how much of it to use.