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# FDA Hits Spanish Drug Facility with 483
- URL: https://www.fdaweb.com/fda-hits-spanish-drug-facility-with-483/
- Published: 2024-09-19T12:00:00.000Z
- Updated: 2026-09-14T14:41:44.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5157818

FDA has issued Laboratorios Farmaceuticos Rovi a four-item[ Form FDA-483](https://www.fda.gov/media/181911/download?ref=fdaweb.com) after inspecting the company’s Madrid, Spain manufacturing facility and documenting significant GMP deficiencies. For example, the agency cited the firm over its written records about its investigations into unexplained discrepancies because they do not always include the conclusions and follow-up actions.

The inspection also cited the firm over its procedures to prevent microbiological contamination of drug products because they are not followed. Additionally, the FDA-483 cited the company’s equipment as inadequate for their intended uses, and it said the responsibilities and procedures applicable to the quality control unit are not in writing and fully followed.