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# Latest FDA Warning Letters
- URL: https://www.fdaweb.com/latest-fda-warning-letters-82/
- Published: 2016-09-13T12:00:00.000Z
- Updated: 2026-09-14T21:31:23.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5136790

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

**American Pharmacy of Illinois, Inc.** (dba Alwan Pharmacy and Compounding Center) Peoria, IL (7/22). FDA investigator inspected drug compounding operation and observed serious deficiencies in its practices for producing sterile drug products. For example, the investigator noted that the firm failed to use a required sterile product in its operationsand did not establish an adequate contact time for the sporicidal agent used to disinfect the aseptic processing areas. Furthermore, the firm failed to demonstrate through appropriate studies that its hoods are able to provide adequate protection of the ISO 5 areas in which sterile products are processed.  
[http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2016/ucm519419.htm](http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2016/ucm519419.htm?ref=fdaweb.com)

**Central Illinois Compounding, Inc.** (dba Preckshot Professional Pharmacy) Peoria, IL (9/2). Inspected Peoria Heights, IL compounding pharmacy and investigator observed serious deficiencies in facility’s practices for producing sterile drug products. For example, the investigator found that facility failed to use a sporicidal agent in the compounding areas. In addition, facility failed to demonstrate through appropriate studies that its hoods are able to provide adequate protection of the ISO 5 area in which sterile products are processed.  
[http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2016/ucm519412.htm](http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2016/ucm519412.htm?ref=fdaweb.com)

**Harrington House Ltd.** Danville, VA (9/2). FDA reviewed firm’s Web site (www.abbeystclare.com) and determined that it is making drug claims for marketed unapproved products. Products distributed by the firm include Abbey St. Clare Botanical Oil #5: Recovery, Abbey St. Clare Lavender High Altitude French Essential Oil, Abbey St. Clare Australian Emu Oil, Abbey St. Clare Kettle Soap – Certified Organic Formulas, Abbey St. Clare Spot Remover & Blemish Control Poultice, and Abbey St. Clare Pomegranate Protection Hydrating Mist.  
[http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2016/ucm519584.htm](http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2016/ucm519584.htm?ref=fdaweb.com)

**Kalman Health & Wellness, Inc.** (dba Essential Wellness Pharmacy) Peoria, IL (7/22). FDA investigators inspected drug compounding operations and observed serious deficiencies in the practices for producing sterile drug products. For example, investigators noted that the HEPA filters and laminar flow hood within the aseptic processing area were not adequately disinfected prior to conducting aseptic production. Investigators also noted that the firm did not use a sporicidal agent and it used non-sterile disinfectants as part of its disinfection program for the aseptic processing area. In addition, they observed brown stains on the HEPA filter in the laminar airflow hood where sterile drug production occurs.  
[http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2016/ucm519404.htm](http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2016/ucm519404.htm?ref=fdaweb.com)

**Pacific Healthcare, Inc.** (dba B&B Pharmacy) Bellflower, CA (9/2). Inspected drug compounding operations and investigators noted the facility was not receiving valid prescriptions for individually-identified patients for a portion of the drug products produced. Investigators also observed serious deficiencies in its practices for producing sterile drug products. For example, investigators observed a hood located on top of a laminated wood table, which may harbor contamination. In addition, they observed poor aseptic practices, including an operator disinfecting his gloves with non-sterile isopropyl alcohol (IPA) while performing aseptic operations as well as an operator entering with exposed skin into the ISO 5 work zone.  
[http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2016/ucm519598.htm](http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2016/ucm519598.htm?ref=fdaweb.com)

**Techni-Med Inc.** (dba The Compounder) Aurora, IL (7/29) FDA investigator inspected drug compounding operation and noted firm was not receiving valid prescriptions for individually-identified patients for a portion of the drug products produced. The investigator also determined that the firm produced domperidone drug products until 5/12 and the drug is not the subject of an applicable *United States Pharmacopeia* or *National Formulary* monograph. In addition, the investigator observed serious deficiencies in its practices for producing sterile drug products. For example, investigator noted that the firm does not include the sampling of personnel gloves involved in aseptic processing as part of your environmental monitoring program. Furthermore, the firm failed to demonstrate through appropriate studies that its hoods are able to provide adequate protection of the ISO 5 areas in which sterile products are processed.  
[http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2016/ucm519422.htm](http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2016/ucm519422.htm?ref=fdaweb.com)