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# Latest FDA Warning Letters
- URL: https://www.fdaweb.com/latest-fda-warning-letters-186/
- Published: 2019-02-26T12:00:00.000Z
- Updated: 2026-09-15T01:07:43.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5143476

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

**Pure Source** Doral, FL (2/20): FDA inspected the firm 2/2018 and cited significant GMP violations for finished pharmaceuticals. For example, Pure Source failed to thoroughly investigate an unexplained discrepancy or failure of a batch or any of its components to meet any of its specifications. The company also failed to establish and document the accuracy, sensitivity, specificity, and reproducibility of its test methods. Additionally, the inspection revealed that Pure Source manufactures and distributes misbranded drugs labeled as homeopathic products.  
[https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm631837.htm](https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm631837.htm?ref=fdaweb.com)

**Proandre SL** Barcelona, Spain (2/13): FDA inspected the firm 6/2018 and cited significant GMP violations for finished pharmaceuticals. For example, The company failed to have, for each batch of drug product, appropriate laboratory determination of satisfactory conformance to final specifications for the drug product, including the identity and strength of each active ingredient, prior to release. Additionally, Proandre failed to follow an adequate written testing program designed to assess the stability characteristics of its drug products.  
[https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm631839.htm](https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm631839.htm?ref=fdaweb.com)