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# Latest FDA Warning Letters
- URL: https://www.fdaweb.com/latest-fda-warning-letters-170/
- Published: 2018-07-31T12:00:00.000Z
- Updated: 2026-09-15T00:22:52.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5142011

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

**Anigan** San Ramon, CA (7/25): FDA inspected the firm in April and cited GMP violations associated with its Class 2 Super Jennie and EvaCup reusable menstrual cups. For example, the firm failed to establish design controls. It also failed to establish procedures for design validation.  
[https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm615066.htm](https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm615066.htm?ref=fdaweb.com)

**Milbar Laboratories** East Haven, CT (7/23): FDA inspected the firm’s drug manufacturing facility 12/2017 and cited significant GMP violations for finished pharmaceuticals. For example, the firm failed to establish an adequate quality control unit with the responsibility and authority to approve or reject all components, drug product containers, closures, in-process materials, packaging materials, labeling, and drug products. It firm also failed to reject lot components that did not meet the appropriate written specification for identity, strength, quality, and purity.  
[https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm614399.htm](https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm614399.htm?ref=fdaweb.com)

  
**Yuki Gosei** Kogyo Co. Tokyo, Japan (7/17): FDA inspected the firm 11/2018 and cited significant GMP deviations for active pharmaceutical ingredients (API). For example, the firm failed to maintain complete data derived from all laboratory tests conducted to ensure the API complies with established specifications and standards. Its quality system was also an issue because it does not adequately ensure the accuracy and integrity of data to support the safety, effectiveness, and quality of drugs it manufactures.