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# Latest FDA Warning Letters
- URL: https://www.fdaweb.com/latest-fda-warning-letters-161/
- Published: 2018-05-15T12:00:00.000Z
- Updated: 2026-09-15T00:05:02.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5141442

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

**Product Quest MFG**, Daytona Beach, FL (4/16): FDA inspected the firm 10/2017 and cited significant GMP violations for finished pharmaceuticals. For example, the firm failed to maintain adequate separate defined areas necessary to prevent contamination or mix-ups. The firm also failed to establish and follow adequate written procedures for cleaning and maintenance of equipment.  
[**https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm606805.htm**](https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm606805.htm?ref=fdaweb.com)

**Reine Lifescience** Gujurat, India (5/9): FDA inspected the firm 11/2017 and cited significant GMP deviations for active pharmaceutical ingredients. For example, the firm failed to validate and verify suitability of its analytical methods. The firm also failed to exercise sufficient controls over computerized systems to prevent unauthorized access or changes to data, and failure to have adequate controls to prevent omission of data.  
[https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm607583.htm](https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm607583.htm?ref=fdaweb.com)