FDA 483 - Massachusetts Public Health Biologic Laboratories - September 29, 2006

An inspection of Massachusetts Public Health Biologic Laboratories, a vaccine manufacturer in Jamaica Plain, MA, revealed significant deficiencies in aseptic processing, environmental controls, and quality system procedures. Issues included inadequate facility design, flawed smoke studies, deviations from SOPs for operations and preventive maintenance, and insufficient handling of sterility test failures and water system deviations. These findings indicate a lack of control over critical manufacturing processes for Tetanus/Diphtheria vaccines.