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# Latest FDA Warning Letters
- URL: https://www.fdaweb.com/latest-fda-warning-letters-156/
- Published: 2018-03-27T12:00:00.000Z
- Updated: 2026-09-14T23:55:36.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5141080

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

**Biotek Inc.** Layton, UT (3/13): FDA inspected the firm 8/2017 and cited it over product claims that cause its dietary supplements to be unapproved drugs. For example, marketing statements for Bio-35 and Gluten-Free Q Iron-Free claim that the “immune system is improved helping to combat stress and disease.” Another product, Lipotropic Formula, is associated with claims that it can improve triglyceride levels in blood.  
[https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm602236.htm](https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm602236.htm?ref=fdaweb.com)

**Clover Custom Blending** Tampa, FL (2/28): FDA inspected the firm 5/2017 and cited significant GMP violations for finished pharmaceuticals. For example, the firm failed to thoroughly investigate unexplained discrepancies and batch failures. It also failed to establish written responsibilities and procedures applicable to its quality control unit. Additionally, the firm failed to maintain adequate separate defined areas necessary to prevent contamination or mix-ups.  
[https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm602039.htm](https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm602039.htm?ref=fdaweb.com)

**Keshava Organics** Maharashtra, India (3/15): FDA inspected the firm’s drug manufacturing facility 5/2017 and cited significant GMP deviations for active pharmaceutical ingredients. For example, it failed to adequately investigate out-of-specification results and implement appropriate corrective actions. The firm also failed to maintain complete laboratory control records for test methods.  
[https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm602671.htm](https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm602671.htm?ref=fdaweb.com)