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# Latest FDA Warning Letters
- URL: https://www.fdaweb.com/latest-fda-warning-letters-89/
- Published: 2016-11-01T12:00:00.000Z
- Updated: 2026-09-14T21:44:06.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5137231

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

**Beijing Taiyang Pharmaceutical Industry Co.** Beijing, China (10/19): FDA attempted to inspect the firm 11/2015 and the firm limited the inspection. Agency investigators observed through a window a warehouse containing numerous drums. When investigators requested access to this warehouse, they were barred from entering until the following day when a significant number of drums had been removed and were not available for inspection. Investigators also documented that the firm’s methods, facilities, or controls for manufacturing, processing, packing, or holding do not conform to current good manufacturing practice. Additionally, investigators observed systemic data manipulation across the facility.  
[http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2016/ucm527005.htm](http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2016/ucm527005.htm?ref=fdaweb.com)

**Option Care Enterprises** (Walgreens Infusion Services) Deerfield, IL (10/19). FDA inspected the firm 8/2015 and observed serious deficiencies in its practices for producing sterile drug products. For example, investigators observed poor personnel aseptic practices. Specifically, while performing aseptic operations, a technician leaned forward into the ISO 5 hood resting both elbows on the hood and covering the ventilation grid.   
[http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2016/ucm526853.htm](http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2016/ucm526853.htm?ref=fdaweb.com)

**Wellcare Rx Investments LLC** (dba Denson’s Specialty Pharmacy) Wheaton, IL (9/30): FDA inspected the firm 11/2015 and noted that the firm was not receiving valid prescriptions for individually-identified patients for a portion of the drug products it produced. In addition, the investigator observed serious deficiencies in practices for producing sterile drug products. For example, the investigator noted that the facility is not adequately designed for sterile drug production. Specifically, the laminar airflow hood, where aseptic production occurs, is located in an unclassified room that does not contain any HEPA filtration.  
[http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2016/ucm526757.htm](http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2016/ucm526757.htm?ref=fdaweb.com)