FDA 483 - Kirkman Laboratories, Inc. - March 15, 2019

Kirkman Laboratories, Inc. in Lake Oswego, OR, was cited for significant deficiencies in its quality control unit, laboratory controls, and stability program during an FDA inspection. Observations included a lack of written quality agreements, unapproved procedures, missing annual product reviews, and inadequate stability testing and data integrity practices. Several issues, such as the quality control unit and investigation failures, were repeat observations.