German Drugmaker Cited for Inadequate CAPAs

The FDA hit German bulk drug substance manufacturer Dynavax GmbH with a Form 483 over seven violations seen at its Düsseldorf facility, including inadequate corrective and preventive actions (CAPAs).

The heavily-redacted observations encountered during the agency’s Feb. 25–March 5 inspection all pertained to the production of the drug substance HBsAg.

The investigator noted several objectionable conditions, including insufficient environmental monitoring and labeling. For example, the storage room used for the substance was not labeled, and for part of the product’s manufacturing process, it had no label identifying its name, date and lot number.