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# Latest FDA Warning Letters
- URL: https://www.fdaweb.com/latest-fda-warning-letters-164/
- Published: 2018-06-05T12:00:00.000Z
- Updated: 2026-09-15T00:10:26.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5141609

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

**Fertility Partnership** St Peters, MO (5/24): FDA inspected the firm in March and cited deviations from the regulations governing human cells, tissues, and cellular and tissue-based products (HCT/Ps). For example, the firm failed to test a specimen from an anonymous or directed donor of reproductive cells or tissue for evidence of infection due to relevant communicable disease agents. The firm also failed to determine and document the eligibility of a donor of reproductive cells or tissue based on the results of donor screening and donor testing.  
[https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm609165.htm](https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm609165.htm?ref=fdaweb.com)

**IDT Australia Ltd.** Victoria, Australia (5/23): FDA inspected the firm 12/2017 and cited significant GMP deviations for active pharmaceutical ingredients and finished pharmaceuticals. For example, the firm failed to adequately investigate out-of-specification results and implement appropriate corrective actions. The firm also failed to ensure that the quality unit investigate and resolve critical deviations.  
h[ttps://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm609195.htm](https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm609195.htm?ref=fdaweb.com)

**Kolmar Korea Co. Ltd.** Sejong-si, Republic of Korea (5/18): FDA inspected the firm 9/2017 and cited significant GMP violations for finished pharmaceuticals. For example, the firm failed to thoroughly investigate any unexplained discrepancy or failure of a batch or any of its components to meet any of its specifications. The firm also failed to follow written procedures applicable to the quality control unit.  
[https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm609136.htm](https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm609136.htm?ref=fdaweb.com)