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# CGMP Violations at Geneva’s Laboratoire Sintyl
- URL: https://www.fdaweb.com/cgmp-violations-at-genevas-laboratoire-sintyl/
- Published: 2016-10-11T12:00:00.000Z
- Updated: 2026-09-14T21:38:51.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5137045

A 6/20-6/23 FDA inspection at Laboratoire Sintyl, Geneva, Switzerland, found numerous violations of current good manufacturing practice for finished pharmaceuticals, according to a 9/29 [Warning Letter](http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2016/ucm524002.htm?ref=fdaweb.com). Specific violations included: 

- failing to establish written policies and procedures applicable to the quality control unit, including the review of out-of-specification results and customer complaints;
- failing to test finished batches of drug products for the identity and strength of active ingredients;
- failing to ensure the identity of components sourced from various suppliers, including active ingredients for its unnamed drug product;
- failing to clean and maintain an unidentified item at appropriate intervals to prevent malfunctions or contamination of drug products;
- failing to establish written procedures for production and process controls, including validation protocols and reports, designed to assure that the company’s drug products have the identity, strength, quality, and purity they purport or are represented to possess; and
- failing to possess data to demonstrate that the chemical and physical properties of its product remain acceptable throughout their shelf lives.

The letter notes that the company reported it has stopped manufacturing its unidentified over-the-counter drug product. If it resumes manufacturing drugs for the U.S. market, the letter says, FDA strongly recommends engaging a consultant to assist it in meeting CGMP requirements. The firm was told to respond with a list of steps taken since the inspection to correct the violations and prevent their recurrence, along with a timetable for completion.