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# Latest FDA Warning Letters
- URL: https://www.fdaweb.com/latest-fda-warning-letters-183/
- Published: 2019-01-29T12:00:00.000Z
- Updated: 2026-09-15T00:58:06.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5143249

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

**Hangzhou Guoguang Touring Commodity Co.** Zhejiang, China (12/14): FDA inspected the firm 4/2018 and cited it for significant GMP violations for finished pharmaceuticals. For example, the firm failed to establish and follow adequate written procedures for cleaning and maintenance of equipment. Additionally, the firm failed to establish an adequate quality control unit with the responsibility and authority to approve or reject all components, drug product containers, closures, in-process materials, packaging materials, labeling, and drug products. FDA recommended that the firm retain a consultant to help it achieve GMP compliance.  
[https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm628942.htm](https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm628942.htm?ref=fdaweb.com)

**University of Miami Reproductive and Fertility Center** Miami, FL (12/3/2018) FDA inspected the center 7/2018 and cited it for significant deviations from the regulations for human cells, tissues, and cellular and tissue-based products. For example, the center failed to determine as ineligible several donors who were identified as having a risk factor that would exclude them. Additionally, the center failed to prominently label a cell/tissue product with a “biohazard legend” if results of any screening or testing performed indicate risk factors for, or clinical evidence of, communicable disease agents or diseases.  
[https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm629069.htm](https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm629069.htm?ref=fdaweb.com)