Emergent’s FDA Audit Indicates Poor Vendor Validation by J & J
(Thursday, April 22, 2021)
Yesterday FDA published the FDA 483 for Emergent’s vaccine manufacturing facility in Baltimore listing a litany of non-compliance findings made by its inspectors, and it points to the abysmal job done by J&J’s vendor validation team. Prior to giving a contract to a vendor it is essential that the client company conduct a thorough review of the vendors processes, visit the facility to verify everything, and implement measures to assure that the facility will maintain a status of compliance while doing the contracted job. The 13-page FDA 483 listed 35 major findings categorized into 9 groups, of which almost 30 of them were related to the site’s compliance with core GMP requirements. FDA inspectors found poor deviation investigation, personnel not following SOPs, unsanitary conditions, peeling paint and chipped floors, residues on the floors and doors, inadequate size and design of the facility, poor training, inadequate equipment, and poor contamination control. These issues should have been detected during a pre-contract vendor audit. Structural integrity of the facility, adequacy of equipment and facility design, and documentation practices are obvious things to assess during a vendor audit. A vendor audit should involve a detailed questionnaire on vendors capabilities, an on-site audit to review compliance and identify areas of improvement, and a post-audit verification that all the potential non-compliance issues have been addressed prior to the contracted work. In an emergency, these tasks can be merged to save time. For example, the questionnaire can be filled during an on-site inspection, additional resources can be provided to address deficiencies, and risk-assessment notes can be created to explain the remaining low-risk deficiencies. Most of the deficiencies identified by FDA inspectors would have been relatively easy to address in the vendor validation phase. It is inexcusable that before contracting Emergent to manufacture one of the most previous products ever manufactured by J&J, its quality assurance team did not verify GMP compliance of the vendor and missed many of these deficiencies. It also seems that Emergent had inadequate QA processes and was poorly prepared for the FDA inspection. FDA inspectors found non-compliance activities by site personnel in their review of video recordings from 2-3 months prior to the FDA visit. It is not clear for the FDA 483 if these were isolated incidences over months of operations or routine practices; these should have been detected by Emergent’s QA and explained to FDA inspectors. Isolated incidences that have been already addressed generally do not end up on FDA 483s. Similarly, residues on walls and floors, chipped or pealing paint inside sterile manufacturing facilities, personnel not following SOPs or not filling logs, are all issues that a robust QA should be able to catch and remedy. The original announcements both from J&J and Emergent stated their internal quality systems “worked as designed” but the FDA findings show that they did not. The hardest part of the story for both J&J and Emergent is that these are self-inflicted injuries that will take a long time to heal.
Dr. Mukesh Kumar
Founder & CEO, FDAMap
Linkedin: Mukesh Kumar, PhD, RAC