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# Latest FDA Warning Letters
- URL: https://www.fdaweb.com/latest-fda-warning-letters-176/
- Published: 2018-10-16T12:00:00.000Z
- Updated: 2026-09-15T00:38:14.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5142599

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

**Hanlim Pharm Co.** Seocho-Dong, South Korea (10/3): FDA inspected the firm in February and cited significant GMP violations for finished pharmaceuticals. For example, the firm failed to follow appropriate written procedures that are designed to prevent microbiological contamination of drug products purporting to be sterile. The firm also failed to establish an adequate system for monitoring environmental conditions in aseptic processing areas.  
[https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm622860.htm](https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm622860.htm?ref=fdaweb.com)

**Ignatius P. Godoy** Paramount, CA (10/1): FDA inspected the clinical investigator in June and cited clinical study violations associated with a trial involving a Quadrivalent Inactivated Influenza Virus Vaccine. For example, the clinical investigator failed to obtain the legally effective informed consent of a subject’s legally authorized representative prior to involving them in research. The investigator also failed to ensure that the investigation was conducted according to the signed investigator statement, the investigational plan, and applicable regulations.  
[https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm623054.htm](https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm623054.htm?ref=fdaweb.com)