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# API Deviations Found in Teva Hangzhou Plant
- URL: https://www.fdaweb.com/api-deviations-found-in-teva-hangzhou-plant/
- Published: 2017-04-25T12:00:00.000Z
- Updated: 2026-09-14T22:19:50.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5138527

A 9/26-9/29 FDA inspection at Teva Pharmaceutical and Chemical (Hangzhou), Zhejiang, China, found significant deviations from current good manufacturing practice for active pharmaceutical ingredients, according to a 4/5 [Warning Letter](https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2017/ucm554461.htm?ref=fdaweb.com). Specific deviations cited in the letter include: 

- failing to establish written procedures to monitor the progress and control the performance of processing steps that may cause variability in API quality characteristics; and
- failing to establish a sampling plan based on scientifically sound sampling practices.

The company’s responses to the findings were inadequate, FDA says. Teva was told to respond with a list of specific actions taken since the inspection to correct the deviations and prevent their recurrence, with a timetable for completion.