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# 2 Observations on GSK Vaccines Unit ’483
- URL: https://www.fdaweb.com/2-observations-on-gsk-vaccines-unit-483/
- Published: 2026-10-27T20:16:13.000Z
- Updated: 2026-10-27T20:16:13.000Z
- Author: David McFarland
- Tags: enforcement

FDA has released the Form FDA-483 issued following a 2/19-2/27 inspection at the GSK Vaccines licensed biological drug manufacturing unit in Marburg, Hassia, Germany. The two inspection [observations](https://www.fda.gov/media/195475/download?ref=fdaweb.com) were:

- failure to validate the cleaning procedures for dedicated equipment used in the manufacture of aluminum hydroxide adjuvant to prevent contamination or carry-over when the adjuvant is a component in several of the company’s licensed U. S. products; and
- failure to thoroughly review any unexplained discrepancy, whether or not the batch has already been distributed.