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# FDA Cites GSK Hungary Vaccine Plant
- URL: https://www.fdaweb.com/fda-cites-gsk-hungary-vaccine-plant/
- Published: 2025-12-19T12:00:00.000Z
- Updated: 2026-09-14T15:29:41.000Z
- Author: David McFarland
- Tags: Biologics, #legacy-id-D5160420

FDA has cited a GlaxoSmithKline biologicals manufacturing site in Hungary for significant lapses in deviation investigations and material controls, including failures to assess worst-case conditions for batches later used in the production of widely used vaccines. The just-posted [FDA Form 483](https://www.fda.gov/media/190226/download?attachment&ref=fdaweb.com) followed an inspection conducted from 1/23 through 1/31 at the company’s licensed biologics manufacturing facility in Godollo, Hungary.

According to the inspection report, FDA investigators found that the company did not adequately investigate manufacturing discrepancies or evaluate worst-case scenarios before releasing affected batches for further processing into finished vaccine products, including Infanrix and Boostrix.

In one observation, FDA cited a 1/2024 deviation involving particulate contamination during manufacturing. While the company identified the presence of particles and submitted samples for analysis, investigators said GSK failed to perform a sufficient risk assessment that considered worst-case conditions. Despite the unresolved questions, the affected batch was released and distributed for further manufacture of Infanrix and Boostrix vaccine lots.

A separate deviation involved 17 storage temperature excursions in which a batch was held outside controlled conditions for approximately 16 hours, with temperatures reaching the upper limits of the acceptable range. FDA said the company failed to assess the potential impact on all affected units and did not adequately justify that its viability testing samples represented worst-case exposure. That material was also released for further manufacturing use.

FDA also cited deficiencies in GSK’s procedures governing the acceptance and rejection of components used in drug substance manufacturing.

A revised standard operating procedure implemented in 3/2024 required visual inspection of certain components before use. However, FDA said the procedure allowed acceptance of materials showing defined levels of defects without any supporting risk assessment or study evaluating the impact of using those materials in the manufacturing process.