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# Latest FDA Warning Letters
- URL: https://www.fdaweb.com/latest-fda-warning-letters-114/
- Published: 2017-05-23T12:00:00.000Z
- Updated: 2026-09-14T22:25:16.000Z
- Author: David McFarland
- Tags: EIRs/483s, #legacy-id-D5138760

Today FDA posted its latest batch of Warning Letters. They can be accessed by clicking on the link following each letter.

**Changzhou Jintan Qianyao Pharmaceutical Raw Material Factory**, Changzhou City, China (5/11):FDA inspected the firm in February and documented significant GMP deviations associated with its active pharmaceutical ingredients. For example, the firm failed to implement a system for managing quality encompassing the organizational structure, procedures, processes and resources. Before 8/2016, the firm did not have any quality-related procedures in place even though it was manufacturing and shipping drugs to the U.S. Also, the firm failed to have laboratory control records that include complete data derived from all laboratory tests conducted to ensure compliance with established specifications and standards.  
[https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2017/ucm558917.htm](https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2017/ucm558917.htm?ref=fdaweb.com)

**Formulife, Inc.** Allen, TX (5/12): FDA inspected the firm’s dietary supplement facility in Dallas, TX and found a number of GMP violations. Based on claims on the company’s Web site, its product Organ Shield is considered an unapproved new drug. For example, one claim stated: “silymarin \[an ingredient in the product\] … is comprised of several flavonolignands that help repair liver cells damaged by toxins…”  
[https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2017/ucm558916.htm](https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2017/ucm558916.htm?ref=fdaweb.com)