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# Latest FDA Warning Letters
- URL: https://www.fdaweb.com/latest-fda-warning-letters-172/
- Published: 2018-08-21T12:00:00.000Z
- Updated: 2026-09-15T00:27:07.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5142167

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

**Hangzhou Karic Commodities** Hangzhou, China (7/31): FDA inspected the firm in March and cited significant GMP violations for finished pharmaceuticals. For example, the firm failed to have, for each batch of drug product, appropriate laboratory determination of satisfactory conformance to final specifications. The firm also failed to conduct at least one test to verify the identity of each component of a drug product. Additionally, it failed to thoroughly investigate any unexplained discrepancy or failure of a batch or any of its components to meet any of its specifications.  
[https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm617355.htm](https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm617355.htm?ref=fdaweb.com)

**Kyowa Hakko Bio** Yamaguchi, Japan (8/10): FDA inspected the firm 9/2017 and cited significant GMP deviations for active pharmaceutical ingredients (APIs). For example, the firm’s quality unit failed to exercise its responsibility to ensure the API manufactured are in compliance with GMPs. It performed retesting or manipulated data after obtaining out-of-specification or other unacceptable results. The firm also failed to exercise sufficient controls over computerized systems to prevent unauthorized access or changes to data, and failed to have adequate controls to prevent omission of data. Additionally, the agency documented repeat observations that were cited in a previous Warning Letter.  
[https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm617419.htm](https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm617419.htm?ref=fdaweb.com)