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# Latest FDA Warning Letters
- URL: https://www.fdaweb.com/latest-fda-warning-letters-83/
- Published: 2016-09-20T12:00:00.000Z
- Updated: 2026-09-14T21:33:45.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5136862

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

**Option Care Enterprises, Inc.** Everett, WA (9/7). FDA investigators inspected the drug compounding operation and observed deficiencies in its practices for producing sterile drug products. For example, the inspection noted that the firm uses a non-sterile product to clean the ISO 5 area. Furthermore, a technician was observed touching the inner liner of a waste receptacle and a metal cart and then performing aseptic operations in the ISO 5 hood without first disinfecting her gloves.  
[http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2016/ucm521013.htm](http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2016/ucm521013.htm?ref=fdaweb.com)

**Jeffreys Drug Store** Canonsburg, PA (8/25). FDA investigators inspected the drug compounding operation and noted the firm was not receiving valid prescriptions for individually-identified patients for a portion of the drug products it was producing. The firm was also cited for producing domperidone products, which is not included in a *United States Pharmacopeia* or *National Formulary* monograph. Additionally, investigators observed serious deficiencies in the firm’s practices for producing sterile drug products. For example, the inspection observed that the firm did not use a sporicidal agent as part of the disinfection program for the aseptic processing areas.  
[http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2016/ucm520399.htm](http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2016/ucm520399.htm?ref=fdaweb.com)

**Sarkli/Repechage, Ltd.** Secaucus, NJ (8/18). FDA reviewed the firm’s Web site and determined that claims made for marketed cosmetics make the products unapproved new drugs. The claims suggest the products are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease, or they affect the structure or any function of the human body. Affected products include Hydra 4 Red-Out Calming Cleanser, Hydra 4 Red-Out Serum, and Biolight Brightening Daytime Protection Cream.  
[http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2016/ucm520655.htm](http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2016/ucm520655.htm?ref=fdaweb.com)

**ZO Skin Health Group, LLC** Beverly Hills, CA (8/29). FDA reviewed the firm’s Web site and determined that claims made for marketed cosmetics make the products unapproved new drugs. The claims suggest the products are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease, or they affect the structure or any function of the human body. Cited products include Ossential Growth Factor Serum Plus, Ossential Daily Power Defense, and Ossential C-Bright Serum 10% Vitamin C.  
[http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2016/ucm521019.htm](http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2016/ucm521019.htm?ref=fdaweb.com)