![From QSR to QMSR: Meeting FDA’s New Requirements From QSR to QMSR: Meeting FDA’s New Requirements](https://www.fdanews.com/ext/resources/Book-Covers-NEW/From-QSR-to-QMSR-500.png?height=200&t=1714569011&width=200)
Home » Japanese Drugmaker Rapped for Cleaning Violations
Japanese Drugmaker Rapped for Cleaning Violations
September 9, 2019
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.
Upcoming Events
-
21Oct