Wyeth BioPharma Division of Wyeth Pharmaceuticals LLC – FDA EIR, May 3, 2019

An FDA pre-license inspection of Wyeth Biopharma Division of Wyeth Pharmaceuticals Inc. in Andover, MA, was conducted from April 29 to May 03, 2019. The inspection covered Quality, Facilities and Equipment, Production, Materials, and Laboratory Control Systems, aimed at ensuring compliance with pharmaceutical manufacturing standards. At the conclusion, a 3-item Form FDA 483 was issued, detailing significant objectionable conditions. The main issues included: 1) Inadequate Written Procedures and Adherence: Procedures for drug substance manufacturing and laboratory operations were either insufficient or not consistently followed, specifically regarding a failed lot inspection, suboptimal sanitization during drug substance filling, and delayed retesting for out-of-specification environmental monitoring results without timely root cause investigations. 2) Poor Facility and Equipment Maintenance: Deficiencies were noted in infrastructure, including gaps around light fixtures, damaged paint, deteriorated sealants in manufacturing areas, rust on HEPA filter screens, and multiple active water leaks across various utility systems. 3) Ineffective Corrective Actions: Prior efforts to prevent insect incursions into manufacturing buildings A and B were deemed ineffective. A prior inspection in January 2019 had also cited inadequate control of critical materials and reagents for testing, which Wyeth addressed by updating relevant standard operating procedures and implementing corrective actions. For the current observations, management acknowledged the findings and committed to addressing the identified deficiencies.