Pexels.com
The U.S. Food and Drug Administration issued 34 warning letters in June that were sent to manufacturers and other companies found to have violated FDA regulations.
“The Warning Letter identifies the violation, such as poor manufacturing practices, problems with claims for what a product can do, or incorrect directions for use,” the FDA reports.
Such letters, which can be sent to product manufacturers, tobacco retailers, drug marketers and advertisers, direct the company to comply with the designated regulations and provide the FDA with a timeline to fix the problems.
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FDA Warning Letters Issued in June
| Issue Date | Company Name | Issuing Office | Subject |
| June 27 | Chukar Cherry Company Inc. | Division of Human and Animal Food Operations West VI | CGMP Regulation for Foods / Adulterated |
| June 25 | Sunshine Mills Inc. | Division of Human and Animal Food Operations East V | Adultered Animal Food / Misbranded |
| June 24 | Abington Memorial Hospital, IRC | Center for Biologics Evaluation and Research | Bioresearch Monitoring Program / IRB |
| June 24 | AllerQuest LLC | Center for Drug Evaluation and Research | CGMP / Finished Pharmaceuticals / Adulterated |
| June 20 | HealthTech International Inc. | Division of Human and Animal Food Operations West IV | Dietary Supplement / Adulterated |
| June 20 | Clinicon Corp. | Division of Medical Device and Radiological Health Operations West | CGMP / QSR / Medical Devices / Adulterated |
| June 20 | Aurobindo Pharma Limited | Center for Drug Evaluation and Research | CGMP / Active Pharmaceutical Ingredient (API) / Adulterated |
| June 18 | Vapejoose Inc. | Center for Tobacco Products | Family Smoking Prevention and Tobacco Control Act / Adulterated / Misbranded |
| June 18 | Smoke Brake Vapes LLC | Center for Tobacco Products | Family Smoking Prevention and Tobacco Control Act / Adulterated / Misbranded |
| June 17 | Ideal Specialty Apothecary Inc. dba Ideal Pharmacy | Division of Pharmaceutical Quality Operations I | Drug Product / Adulterated |
| June 17 | Sweet Production Inc. | Division of Human and Animal Food Operations West V | CGMP / Food / Prepared, Packed or Held Under Insanitary Conditions / Adulterated |
| June 13 | Akorn Inc. | Division of Pharmaceutical Quality Operations I | CGMP / Finished Pharmaceuticals / Adulterated |
| June 13 | Rxhomeo Private Limited | Center for Drug Evaluation and Research | CGMP / Finished Pharmaceuticals / Adulterated |
| June 13 | Allandale Dairy | Division of Human and Animal Food Operations West I | Illegal Drug Residue |
| June 12 | SnugZ USA, Inc. | Division of Pharmaceutical Quality Operations III | CGMP / Finished Pharmaceuticals / Adulterated |
| June 11 | Asclemed USA Inc. dba Enovachem | Division of Pharmaceutical Quality Operations IV | CGMP / Active Pharmaceutical Ingredient (API) / Adulterated |
| June 11 | Cali Botanicals, LLC | Center for Drug Evaluation and Research | Unapproved New Drug / Misbranded |
| June 10 | Xi'an Livingbond Nonwoven Products Corp., Ltd. | Center for Drug Evaluation and Research | CGMP / Finished Pharmaceuticals / Adulterated / Misbranded |
| June 7 | Imprimis NJOF, LLC | Division of Pharmaceutical Quality Operations I | Drug Product / Adulterated |
| June 7 | Earthworks Health | Office of Human and Animal Food- West Division II | Unapproved New Drugs / Misbranded |
| June 7 | Hype City Vapors, LLC | Center for Tobacco Products | Family Smoking Prevention and Tobacco Control Act / Adulterated / Misbranded |
| June 7 | Solace Technologies, LLC d / b / a Solace Vapor | Center for Tobacco Products | Family Smoking Prevention and Tobacco Control Act / Adulterated / Misbranded |
| June 7 | Humble Juice Co. LLC | Center for Tobacco Products | Family Smoking Prevention and Tobacco Control Act / Adulterated / Misbranded |
| June 7 | Artist Liquids Laboratories LLC,
d / b / a Artist Liquid Labs | Center for Tobacco Products | Family Smoking Prevention and Tobacco Control Act / Adulterated / Misbranded |
| June 6 | US Pharmaceuticals Inc. | Division of Pharmaceutical Quality Operations I | CGMP / Finished Pharmaceuticals / Adulterated |
| June 6 | PRL Inc | Division of Human and Animal Food Operations East V | CGMP / Dietary Supplement / Adulterated / Misbranded |
| June 5 | 9 South Vapes, LLC | Center for Tobacco Products | Family Smoking Prevention and Tobacco Control Act / Adulterated / Misbranded |
| June 5 | Any Cig | Center for Tobacco Products | Family Smoking Prevention and Tobacco Control Act / Adulterated / Misbranded |
| June 5 | Inhale Hookah & Accessories | Center for Tobacco Products | Family Smoking Prevention and Tobacco Control Act / Adulterated / Misbranded |
| June 5 | VapeKing ELiquid Engineering | Center for Tobacco Products | Family Smoking Prevention and Tobacco Control Act / Adulterated / Misbranded |
| June 4 | B & B Pharmaceuticals, Inc. | Division of Pharmaceutical Quality Operations IV | Unapproved New Drug / Misbranded |
| June 4 | Advanced Botanical Consulting & Testing Inc dba ABC Testing | Division of Pharmaceutical Quality Operations IV | CGMP / Finished Pharmaceuticals / Adulterated |
| June 4 | Spectrum Laboratory Products | Division of Pharmaceutical Quality Operations IV | CGMP / Active Pharmaceutical Ingredient (API) / Adulterated |
| June 3 | Wewoka Animal Hospital | Division of Human and Animal Food Operations West III | New Animal Drug / Adulterated |
