Abbott Warned for GMP Violations

The Abbott Diagnostics division of Abbott Laboratories received a warning letter after an FDA inspection found its diagnostic analyzers were adulterated due to good manufacturing practice violations.

The agency found several problems with the firm's responses, but is not satisfied with the pace and results of the corrective actions "as they have not been effectively, timely and globally implemented" for the entire family of analyzers.

The firm's responses are therefore incomplete until Abbott adequately corrects recurring inspectional observations, specific issues cited in the warning letter and various quality issues in all of the analyzers, the FDA said.