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# QS Violations Found at Switzerland’s Lonza Group
- URL: https://www.fdaweb.com/qs-violations-found-at-switzerlands-lonza-group/
- Published: 2017-05-09T12:00:00.000Z
- Updated: 2026-09-14T22:22:39.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5138642

A 1/18-2/6 FDA inspection at Lonza Group, Basel, Switzerland, found Quality System Regulation violations in the firm’s work as a contract manufacturer of unidentified Class 2 medical devices. A 4/21 [Warning Letter](https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2017/ucm556170.htm?ref=fdaweb.com) says that specific violations noted on an FDA-483 included: 

- failing, where the results of a process cannot be fully verified by subsequent inspection and test, to validate the process with a high degree of assurance and to approve according to established procedures;
- failing to develop, conduct, control, and monitor production processes to ensure that a device conforms to its specifications;
- failing to establish and maintain procedures for implementing corrective and preventive action; and
- failing to adequately establish procedures to control environmental conditions.

The firm’s responses to the inspection observations were partially adequate or their adequacy could not be determined. The letter also noted that the firm failed to test numerous products lots for sterility based on a United States Pharmacopeia test or an equivalent method. FDA says the firm used a surrogate sterility test that lacks a representative sample in the batch and is insufficiently sensitive.

The company was told to respond with a list of steps taken to correct the violations, documentation of each step, and a timetable for completion.