2013
Anazaohealth Corporation, Tampa, FL- 483 Issued 2/22/2013 (PDF - 857KB)
ApothéCure, Inc., Dallas, TX
- Firm Press Release: ApothéCure, Inc. Recalls All Lots of All Sterile Products Compounded, Repackaged, and Distributed by ApothéCure, Inc. Due to Sterility Assurance Concerns (4/15/2013)
Avella of Deer Valley, Inc, Phoenix, AZ
- 483 Issued 2/25/2013 (PDF - 1010KB)
Axium Healthcare Pharmacy (dba Balanced Solutions Compounding), Lake Mary, FL
- 483 Issued 3/15/2013 (PDF - 638KB)
- 483 Issued 1/29/2013 (PDF - 11.7MB)
Central Admixture Pharmacy Services, Inc. (CAPS), Wallingford, CT
- 483 Issued 2/19/2013 (PDF - 8MB)
Central Admixture Pharmacy Services, Inc. (CAPS), Homewood, AL
- 483 Issued 3/7/2013 (PDF - 600KB)
Central Admixture Pharmacy Services, Inc., (CAPS), Kansas City, MO
- 483 Issued 2/28/2013 (PDF - 697KB)
Central Admixture Pharmacy Services, Inc., (CAPS), Livonia, MI
- 483 Issued 2/28/2013 (PDF - 790KB)
Central Admixture Pharmacy Services, Inc., (CAPS), Chicago, IL
- 483 Issued 2/22/2013 (PDF - 974KB)
Clinical Specialties Compounding Pharmacy, Augusta, GA
- 483 Issued 4/2/2013 (PDF - 5.4MB)
- Firm News Release: Clinical Specialties Compounding Pharmacy Recalls All lots of Sterile Products Repackaged and Distributed by Clinical Specialties Compounding Due to Lack of Sterility Assurance (03/20/2013)
College Pharmacy Incorporated, Colorado Springs, CO
- 483 Issued 3/15/2013 (PDF - 1.3MB)
The Compounding Shop St. Petersburg, FL
- Amended 483 Issued 3/25/2013 (PDF - 10MB)
- 483 Issued 3/22/2013 (PDF - 1.3MB)
- 483 Issued 12/13/2012 (PDF - 577KB)
Drugs are Us, Inc. (dba Hopewell Pharmacy), Hopewell, NJ
- 483 Issued 3/21/2013 (PDF - 1.5MB)
Foundation Care LLC, Earth City, MO
- 483 Issued 3/19/2013 (PDF - 867KB)
- 483 Issued 3/15/2013 (PDF - 4.9MB)
- Firm Press Release: Green Valley Drugs Announces Voluntary Nationwide Recall of All Lots of All Sterile Products Compounded, Repackaged, and Distributed by Green Valley Drugs Due to Quality Control Concerns (4/5/2013)
Home Intensive Care Pharmacy, Inc., San Antonio, TX
- 483 Issued 3/1/2013 (PDF - 1.1MB)
IV Solutions of Lubbock, Lubbock, TX
- 483 Issued 3/20/2013 (PDF - 3.7MB)
Lee and Company dba Lee Pharmacy, Inc., Fort Smith, AR
- 483 Issued 2/21/2013 (PDF - 2.6MB)
Lowlite Investments, Inc. (dba Olympia Pharmacy), Orlando, FL
- 483 Issued 3/21/2013 (PDF - 717KB)
Lowlyn Pharmacies, Inc., Blanchard, OK
- 483 Issued 3/8/2013 (PDF - 732KB)
Medaus, Inc., Birmingham, AL
- 483 Issued 3/22/2013 (PDF - 712KB)
Medi-Fare Drug & Home Health Center, Inc., Blacksburg, SC
- 483 Issued 1/18/2013 (PDF - 3.5MB)
- Warning Letter issued 3/07.2013
MedPrep Consulting, Tinton Falls, NJ
- 483 Issued 4/3/2013 (PDF - 6.9MB)
- FDA Press Release: FDA alerts health care providers of recall of all sterile drug products by Med Prep Consulting in New Jersey (03/18/2013)
- Firm News Release: Medprep Consulting Inc. Announces Voluntary Nationwide Recall Of All Lots Of All Compounded Products Due To Potential Mold Contamination (03/20/2013)
- Firm News Release: MedPrep Consulting Inc. Announces Voluntary Nationwide Recall Of All Lots Of All Compounded Products Due To Potential Mold Contamination (03/17/2013)
- Firm News Release: MedPrep Consulting Inc. Announces Voluntary Nationwide Recall Of All Lots Of Magnesium Sulfate 2gm In Dextrose 5% In Water, 50ml For Injection Due To Mold Contamination (03/16/2013)
Nora Apothecary and Alternative Therapies, Inc., Indianapolis, IN
- 483 Issued 3/21/2013 (PDF - 309KB)
NuVision Pharmacy, Dallas TX
- Firm Press Release: NuVision Pharmacy Recalls All Lots of All Lyophilized Products Compounded by NuVision Pharmacy Due to Sterility Assurance Concerns (4/15/2013)
Oakdell Pharmacy, Inc., San Antonio, TX
- 483 Issued 3/1/2013 (PDF - 1.1MB)
Pallimed Solutions, Inc., Woburn, MA
Pentec Health, Inc, Boothwyn, PA
- 483 Issued 4/1/2013 (PDF - 924KB)
PharMEDium Services LLC, Memphis, TN
- 483 Issued 3/22/2013 (PDF - 10.4MB)
PharMEDium Services LLC, Edison, NJ
- 483 Issued 2/28/2013 (PDF - 2MB)
PharMEDium Services, LLC, Lake Forest, IL
- Other Action: FDA letter to firm (2/5/13)
PharMEDium Service, Inc., Sugarland, TX
- 483 Issued 2/27/2013 (PDF - 1.1MB)
PharMEDium Services, LLC, Cleveland, MS
- 483 Issued 2/22/2013 (PDF - 1.9MB)
Portage Pharmacy, Inc., Portage, MI
- 483 Issued 3/6/2013 (PDF - 8.9MB)
- 483 Issued 2/7/2013 (PDF - 195KB)
RxSouth, LLC (dba RX3 Pharmacy), Chester, VA
- 483 Issued 12/14/2012 (PDF - 5.1MB)
Stewart Compounding Pharmacy, Fayetteville, NC
- 483 Issued 3/25/2013 (PDF - 7.3MB)
Triangle Compounding, Cary, NC
- 483 Issued 3/1/2013 (PDF - 880KB)
University Pharmacy, Inc., Salt Lake City, UT
- 483 Issued 2/26/2013 (PDF - 645KB)
- 483 Issued 3/13/2013 (PDF - 393KB)
- 483 Issued 2/11/2013 (PDF - 10.9MB)
Source found here
1 comment:
"Regulatory Colonoscopy"
yes - there will be pushback from pharmacies who do not like the FDA inspections. Expect more and more pharmacies to refuse to allow the inspectors in without search warrants.
Anazaohealth Corporation, Tampa, FL
• 483 Issued 2/22/2013 (PDF - 857KB)
TRANSCRIPT FROM THE APRIL 2-3, 2013 FLORIDA BOARD OF PHARMACY MEETING:
Ed Bayo approached the Board to voice displeasure with the FDA and their inspections of compounding pharmacies. Mr. Bayo believes there are jurisdiction issues with the FDA’s authority to do so. Mr. Bayo went on to describe the inspections as a “regulatory colonoscopy”.
David Joseph (AnazaoHealth) speaks in support of Mr. Bayo’s comments. Mr. Joseph stated that the FDA entered his pharmacy claiming to be conducting a G.M.P. audit as opposed to USP797 and that the FDA has an agenda by conducting these inspections. Mr. Joseph then went on to commend the Board for their actions taken on the issue of compounding and improvements in inspection processes.
--
Kenneth Woliner, MD
www.holisticfamilymed.com
Post a Comment