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# 6 Observations in Gadea Biopharma FDA-483
- URL: https://www.fdaweb.com/6-observations-in-gadea-biopharma-fda-483/
- Published: 2018-12-05T12:00:00.000Z
- Updated: 2026-09-15T00:48:56.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5142962

FDA has released the FDA-483 issued following a 10/8-10/16 inspection at Gadea Biopharma, a Leon, Spain, contract sterile injectable drug products manufacturer. The six inspection observations [are](https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/CDERFOIAElectronicReadingRoom/UCM627530.pdf?ref=fdaweb.com): 

- information stated in the submitted drug application is not exactly as is on site;
- labeling equipment is not qualified in preparation for commercialization of drug product;
- there are no established written procedures for handling labeling and packing operations;
- the Certificate of Analysis from the drug application does not match the raw data from the analytical test records and specification sheet;
- original records of analysis submitted in the drug application were not available; and
- there is no written procedure in the event of change in the version of the Certificate of Analysis.