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# Gascó Industrial Warned on GMPs
- URL: https://www.fdaweb.com/gasco-industrial-warned-on-gmps/
- Published: 2023-02-28T12:00:00.000Z
- Updated: 2026-09-14T18:17:31.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5153868

FDA has sent Gascó Industrial Corp. in Gurabo, Puerto Rico, a Warning Letter after inspecting its manufacturing facility and citing significant GMP violations. For example, the 2/17 letter said the company failed to maintain adequate separate defined areas necessary to prevent contamination or mix-ups. The inspection also found that Gascó’s quality control unit failed to exercise its responsibility to ensure drug products manufactured are in compliance with GMPs. Specifically, the letter says the quality unit failed to ensure the following:

- Adequate testing of incoming components for identity, purity, strength, and other appropriate quality attributes
- Adequate chemical and microbial testing and appropriate specifications for finished drug products
- Investigations of unexplained discrepancies or failures of a batch or any of its components to meet any of its specifications
- Adequate training for employees engaged in the manufacture, processing, packing, or holding of drug products
- Establishment of a stability program
- Establishment of adequate procedures describing out-of-specifications, change controls, annual product reviews, and good documentation practices