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# Latest FDA Warning Letters
- URL: https://www.fdaweb.com/latest-fda-warning-letters-125/
- Published: 2017-08-08T12:00:00.000Z
- Updated: 2026-09-14T22:39:47.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5139338

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

**Cellex-C International** Toronto, Canada (8/2): FDA inspected the firm in January and cited significant GMP violations for finished pharmaceuticals. For example, the firm failed to have, for each batch of drug product, appropriate laboratory determination of satisfactory conformance to final specifications for the drug product. The firm also failed to test samples of each component for conformity with all appropriate written specifications for identity, purity, strength, and quality. And the company failed to establish written responsibilities and procedures applicable to the quality control unit.  
[https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2017/ucm570094.htm](https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2017/ucm570094.htm?ref=fdaweb.com)

  
**Skin Sciences Laboratory** Manggahan Pasig City, Philippines (7/28): FDA inspected the firm in January and cited significant GMP violations for finished pharmaceuticals. During the inspection, an FDA investigator noted that the firm does not have laboratory determinations of satisfactory conformance to final specifications for its drug products. The firm also failed to withhold from use each lot of components, drug product containers, and closures until the lot had been sampled, tested, or examined, as appropriate, and released for use by the quality control unit.  
[https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2017/ucm569981.htm](https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2017/ucm569981.htm?ref=fdaweb.com)