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# Latest FDA Warning Letters
- URL: https://www.fdaweb.com/latest-fda-warning-letters-152/
- Published: 2018-02-27T12:00:00.000Z
- Updated: 2026-09-14T23:25:44.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5140858

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

**Alchymars ICM SM Private Ltd.** Chennai, India (2/16): FDA inspected the firm 9/2017 and cited significant GMP deviations for active pharmaceutical ingredients. For example, the firm failed to have laboratory control records that include complete data derived from all laboratory tests conducted to ensure its APIs comply with established specifications and standards. FDA also found that the firm was falsifying laboratory data. Additionally, it failed to properly maintain equipment and to keep complete records of major equipment maintenance.  
[https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm597706.htm](https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm597706.htm?ref=fdaweb.com)

**Nowcos Co., Ltd.** Seoul, South Korea (2/14): FDA inspected the firm 8/2017 and cited significant GMP for finished pharmaceuticals. For example, the firm failed to establish written procedures for production and process controls. The firm also failed to establish laboratory controls that include scientifically sound and appropriate specifications, standards, sampling plans, and test procedures designed to assure that components, drug product containers, closures, in-process materials, labeling, and drug products conform to appropriate standards.  
[https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm597518.htm](https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm597518.htm?ref=fdaweb.com)

**Shanghai Weierya Daily Chemicals Factory** Shanghai, China (2/7): FDA inspected the firm 4/2017 and cited significant GMP violations for finished pharmaceuticals. For example, the firm failed to conduct appropriate laboratory testing, as necessary, of each batch of drug product. The firm also failed to ensure the identity of components, including its active ingredients and excipients from various suppliers.  
[https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm597899.htm](https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm597899.htm?ref=fdaweb.com)