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# Latest FDA Warning Letters
- URL: https://www.fdaweb.com/latest-fda-warning-letters-84/
- Published: 2016-09-27T12:00:00.000Z
- Updated: 2026-09-14T21:35:11.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5136927

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

**Ajes Pharmaceuticals, LLC.** Copiague, NY (9/09). FDA inspected the firm’s dietary supplement facility and found serious GMP violations. For example, the firm failed to establish product specifications for the identity, purity, strength, and composition of its finished batches, and for limits on those types of contamination that may adulterate finished batches. Additionally, the firm failed to establish identity specifications for each component that you use in the dietary supplement manufacturing. And the firm did not collect and hold reserve samples of each lot of packaged and labeled dietary supplements that it distributes.  
[http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2016/ucm521968.htm](http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2016/ucm521968.htm?ref=fdaweb.com)

**Cheng Fong Chemical Co. Ltd.** Taoyuan City 337, Taiwan (9/15). FDA inspected the active pharmaceutical ingredients (API) manufacturer and found GMP deviations. For example, the firm failed to have an adequate maintenance procedure to prevent contamination or carry-over of a material that would alter the quality of the API. Investigator observed corrosion, pitting, dirt, and leaks, on and around the drug manufacturing equipment. The firm also failed to adequately conduct investigations and extend the investigations to other batches that may have been associated with a failure or deviation. And it failed to adequately investigate customer complaints for black or foreign particles in finished product.  
[http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2016/ucm521320.htm](http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2016/ucm521320.htm?ref=fdaweb.com)

**Elite Laboratories, Inc.** Northvale, NJ (8/25). FDA inspected the firm and found serious violations of Postmarketing Adverse Drug Experience reporting requirements. For example, the firm failed to develop adequate written procedures for the surveillance, receipt, evaluation, and reporting of postmarketing adverse drug experiences. Also, the firm’s standard operating procedures fail to address how to monitor and receive ADEs from any source, foreign and domestic. And FDA determined that the firm submitted about half of the required 15-day alert reports late.  
[http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2016/ucm521289.htm](http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2016/ucm521289.htm?ref=fdaweb.com)