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# 6 Observations on Regeneron FDA-483
- URL: https://www.fdaweb.com/6-observations-on-regeneron-fda-483/
- Published: 2024-11-26T12:00:00.000Z
- Updated: 2026-09-14T14:48:01.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5158269

FDA has released the form [FDA-483](https://www.fda.gov/media/183808/download?ref=fdaweb.com) issued following a 3/6-3/14/2023 inspection at the Regeneron Ireland Designated Activity Company bulk drug substance manufacturing facility in Limerick, Ireland. The six inspection observations were:

- failure of the quality unit to ensure issuance of documents is controlled and original records are maintained;
- failure to establish and follow scientifically sound test procedures;
- failure of control records to contain complete data derived from all tests;
- failure to thoroughly investigate deviations from established procedures;
- failure to appropriately monitor air handling systems and to take appropriate action when limits are exceeded; and
- failure of the quality unit to thoroughly review data.