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# CGMP Deviations Found in Spain’s Interquim
- URL: https://www.fdaweb.com/cgmp-deviations-found-in-spains-interquim/
- Published: 2016-12-06T12:00:00.000Z
- Updated: 2026-09-14T21:52:51.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5137498

A 5/2-5/6 FDA inspection at Interquim, Barcelona, Spain, found significant deviations from current good manufacturing practice for active pharmaceutical ingredients (API), according to an 11/22 [Warning Letter](http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2016/ucm530789.htm?ref=fdaweb.com). Specific deviations included: 

- failing to have adequate cleaning procedures that define and justify acceptance criteria for residues;
- failing to construct equipment so that surfaces that contact raw materials, intermediates, or API do not alter the quality of API beyond established specifications; and
- quality unit failure to ensure that there is stability data to support retest or expiry dates and storage conditions on API and/or intermediates.

The company was told to respond with a list of steps taken since the inspection to correct the deviations and prevent their recurrence.