Boehringer Ingelheim Lands 483

The FDA has handed Boehringer Ingelheim a 10-observation Form 483 for delays with a field alert report, as well as sanitation and sterilization procedures at a site in Germany.

The facility analyzed returned samples after some consumer complaints, and it determined on May 12, 2015, that a spray product did not meet dose specifications. Although it was required to file a field alert report within three working days, the facility waited until June 25, the FDA says.

The Feb. 29 to March 8 inspection found the plant did not test in-process materials for certain quality attributes to ensure they are consistent with final specifications.