Human Medications, Human Drugs, Animal Medications, Animal Drugs, Pharmacy law, Pharmaceutical law, Compounding law, Sterile and Non Sterile Compounding 797 Compliance, Veterinary law, Veterinary Compounding Law; Health Care; Awareness of all Types of Compounding Issues; Pharmacy Benefit Managers (PBMs), Outsourcing Facilities Food and Drug Administration and Compliance Issues
Wednesday, September 30, 2015
Shuttered Compounder Warned Over Sterility Issues
Despite having been closed for more than a year with no plan to reopen, the FDA issued a warning letter to Specialty Medicine Compounding Pharmacy for a litany of cGMP violations, including poor sterile processing controls.
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Attix Pharmaceuticals + American Pharmaceutical Ingredients. Both have been run by the same person. Karl Jebailey. Same practices. Same story. FDA and the FL, MI, state boards need to piece this picture together. ALL PRODUCTS FROM CHINA. NON FDA INSPECTED FACILITIES. Putting U.S citizens at risk. on High Importance! Very Long List of Compounded Drugs from The Compounding Pharmacy of America found on FDA Enforcement Report dated September 23, 2015
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www.attixpharmaceuticals.com www.darmerica.com Fast one past FDA? on High Importance! South Coast Specialty Compounding INC. dba Park Compounding Recall of Cisapride due to the manufacturer of the API: Attix Pharmaceuticals recalling because of the products potentially being contaminated with penicillin
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California Board of Pharmacy Cease and Desist order dated 9/16/2015 against US Compounding Inc. Conway, AR
US Compounding Inc., NSC 99495, Administrative Case AC 5624
Conway, AR
Effective 9/16/2015 US Compounding Inc. shall immediately cease and desist from compounding sterile injectable products for shipment into California.
View Order
Conway, AR
Effective 9/16/2015 US Compounding Inc. shall immediately cease and desist from compounding sterile injectable products for shipment into California.
View Order
California Board of Pharmacy Accusation filed 8/10/2015 against Unique Pharmaceuticals LTD, Temple, TX
Unique Pharmaceuticals LTD, NRP 534 & NSC 99112, Administrative Case 5282
Temple, TX
Accusation Filed 8/10/2015; Case pending.
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Temple, TX
Accusation Filed 8/10/2015; Case pending.
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California Board of Pharmacy Accusation and Petition to Revoke Probation Filed 8/10/2015 against Santa Clara Drug " The Compounding Shop"
Santa Clara Drug “The Compounding Shop”, PHY 51229, Administrative Case 5380
San Jose, CA
Accusation and Petition to Revoke Probation Filed 8/10/2015; Case pending.
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San Jose, CA
Accusation and Petition to Revoke Probation Filed 8/10/2015; Case pending.
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California Board of Pharmacy Accusations against California Pharmacy and Compounding Center filed 8/27/2015
California Pharmacy and Compounding Center, PHY 49828 & LSC 99542, Administrative Case 4628
Newport Beach, CA
First Amended Accusation Filed 8/27/2015; Case pending.
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Newport Beach, CA
First Amended Accusation Filed 8/27/2015; Case pending.
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