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# Latest FDA Warning Letters
- URL: https://www.fdaweb.com/latest-fda-warning-letters-103/
- Published: 2017-03-07T12:00:00.000Z
- Updated: 2026-09-14T22:10:18.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5138140

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

**Denttio, Inc.** Los Angeles, CA (2/23): FDA inspected the firm 8/2016 and documented GMP deficiencies related to its manufacture of digital x-ray image receptors and intraoral microscope/cameras. For example, FDA said the firm failed to establish procedures for receiving, reviewing, and evaluating complaints by a formally designated unit. The firm also failed to establish procedures for corrective and preventive action. Additionally, FDA cited it for failing to perform device software validation and risk analysis.  
[https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2017/ucm543694.htm](https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2017/ucm543694.htm?ref=fdaweb.com)

**Megafine Pharma Ltd.** Mumbai, India (2/24): FDA inspected the firm 9/2016 and documented significant drug GMP deviations. For example, FDA cited the firm’s quality unit for using sourced material from a facility on an agency Import Alert. The inspection also found that interior surfaces of its drug manufacturing equipment were not clean as required by procedures.  
[https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2017/ucm544066.htm](https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2017/ucm544066.htm?ref=fdaweb.com)  
  
**Morton Grove Pharmaceuticals** Morton Grove, IL (2/17): FDA inspected the firm 2/2016 and documented significant GMP violations for finished pharmaceuticals. FDA investigators documented that the firm’s investigations into out-of-specification test results were not thorough, timely, or based on scientific rationales. The firm also was cited for multiple batches of fluticasone propionate nasal spray failed their release criteria that were explained as analyst error without proper scientific justification. In addition, the inspection revealed that the firm failed to submit field alert reports.  
[https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2017/ucm545133.htm](https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2017/ucm545133.htm?ref=fdaweb.com)