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# Latest FDA Warning Letters
- URL: https://www.fdaweb.com/latest-fda-warning-letters-128/
- Published: 2017-08-29T12:00:00.000Z
- Updated: 2026-09-14T22:44:36.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5139499

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

**Hetero Labs Limited** Hyderabad, India (8/15): FDA inspected the firm’s facility 12/2016 and documented 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. Specifically,investigations into process deviations and out-of-specification laboratory results are found to be insufficient and do not include scientifically-supported conclusions. Additionally, the firmfailed to clean, maintain, and sanitize or sterilize equipment and utensils at appropriate intervals to prevent malfunctions or contamination.[https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2017/ucm573005.htm](https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2017/ucm573005.htm?ref=fdaweb.com)

**Total Nutrition** Farmingdale, NY (8/16): FDA inspected the firm 4/24 and documented significant GMP violations for dietary supplements. The agency also reviewed the firm’s product labels, which establish that the products are drugs because they are intended for use in the cure, mitigation, treatment, or prevention of disease.  
[https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2017/ucm572479.htm](https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2017/ucm572479.htm?ref=fdaweb.com)