AnuMed International, LLC
AnuMed International, LLC, a Phoenix-based drug manufacturer, received an FDA Warning Letter on August 20, 2024, citing multiple unapproved new drugs sold without FDA approval, including a 'Semaglutide Homeopathic Formula,' bio-identical hormone creams, and various supplement products making disease treatment claims. The company's products were also found to be misbranded—falsely implying FDA approval by labeling products as made in an 'FDA Approved Facility' or 'FDA registered facility'—and adulterated due to serious CGMP violations including failure to perform identity testing on components such as glycerin and ethanol. FDA demanded a written response within 15 working days and warned that failure to comply could result in seizure or injunction.
Flagged claims (24)
Black Walnut which has anti-fungal and antibacterial properties and can kill intestinal parasites like roundworm and tapeworm. It helps to clean out any toxins and dangerous pathogens.
With Hyaluronic Acid . . . May Increase Calcium Absorption . . . PSORIASIS & ECZEMA RELIEF . . . May help relieve skin flares caused by Psoriasis & Eczema. . . . Vitamin D is necessary for strong bones and teeth. . . . May Help muscle function & support immune system. . . . May help heal wounds faster such as fading bruising.
Curcumin and other chemicals in turmeric might decrease swelling (inflammation). Because of this, turmeric might be beneficial for treating conditions that involve inflammation. Has been known to help with the reduction of inflammation, pain
Ultimate Defense from cold, Flu [influenza], Virus [viral infection], allergy
#1 Recommended Estriol Cream for Menopause Relief, Mood Swings, Hot Flashes, Breast soreness . . . Natural Hormone Balance
Natural Bio-Identical BIO-EST 2.5mg may help with menopause symptoms. . . . BENEFITS . . . Lower the risk of urinary tract infections (UTIs) . . . Strengthen bones and prevent osteoporosis
Dementia and Cognitive Abilities: . . . Research has indicated an association between low levels of B-12 and cognitive decline. As a result, the B-12 . . . solution may help support and replace the lack of the nutrient while improving cognitive function.
FDA inspected and Certified Facility
Has Zinc for which . . . may help combat colds, upper respiratory infections and viruses [viral infection]. . . . This product not only boosts immune system to help make body strong in order to combat most viruses [viral infection] and infections
A proprietary blend of herbals along with zinc to help fight and eliminate parasites in the body
Highly Effective for Leg Cramps, Muscle Soreness, Nighttime Leg Discomfort, Inflammation Relief
FDA * APPROVED * FACILITY
Natural Bio-Identical Bio-EST 5mg may help with menopause symptoms. . . . BENEFITS . . . Lower the risk of urinary tract infections (UTIs) . . . Strengthen bones and prevent osteoporosis
Best protection support from cold, flu [influenza], virus [viral infection]
CRAVINGS APPETITE WEIGHT LOSS
ANUMED – All Natural Bioidentical DHEA 20mg Cream . . . for Hormone Balance, Mood, Immune System . . . Natural Balancing of Hormone Levels, Promotes Mood, Immune System, Anti-Aging, Energy, Metabolism.
Heart Disease: Research has found that B-12 in combination with B-6 and folic acid may help regulate and decrease the levels of homocysteine in the blood system, which are known to increase the chances of cardiovascular disease.
5 Benefits of Natural Progesterone Cream with ISO99: . . . Relieves Menopause Symptoms . . . promote bone density . . . Boosts Fertility . . . preventing miscarriage. . . . Treats Fibroid Tumors . . . Helps Endometriosis . . . Balance Hormones and Relieve PMS Symptoms . . . Relieves Inflammation
Research studies have indicated that K2 intake can decrease bone loss among those with Osteoporosis.
INDICATIONS: It may help to temporarily reduce minor hunger pangs and control appetite to support weight loss efforts.
Ultimate Defense from Cold, Flu [influenza], Virus [viral infection], Allergy
For maximum effectiveness repeat 2 to 3 times per day until desired weight or craving control is achieved. Continue as needed if cravings arise and to help avoid weight regain.
Wormwood kills adult parasites and especially pinworms.
Certified FDA registered facility
Required actions (4)
Please notify FDA in writing, within 15 working days of receipt of this letter, of the specific steps you have taken to address any violations.
Failure to adequately address this matter may result in legal action including, without limitation, seizure, and injunction.
A commitment to provide test results for components used in the manufacture of your drug products, no later than 30 calendar days from the date of this letter, including testing retains for all lots of drug components at high-risk for DEG and EG contamination, and pharmaceutical alcohol for methanol contamination.
Based upon the nature of the violations we identified at your firm, you should engage a consultant qualified as set forth in 21 CFR 211.34 to evaluate your operations and to assist your firm in meeting CGMP requirements. The qualified consultant should also perform a comprehensive six-system audit of your entire operation for CGMP compliance and evaluate the completion and efficacy of your CAPA before you pursue resolution of your firm's compliance status with FDA.
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