In January, the FDA posted 12 Form 483s and one untitled letter to compounding/outsourcing facilities. We list them below.
And, we reviewed the FDAzilla Store to see which 483s were most-purchased and trending during January.
483s to Compounding/Outsourcing Facilities
Abilene Nuclear LLC
Abilene Nuclear LLC (Abilene, TX) received a form 483 at the end of an inspection ending November 7, 2019.
Apex Pharmacy LLC
Apex Pharmacy LLC (Beckley, WV) received a form 483 at the close of inspection on November 7, 2019.
Auro Pharmacies
Auro Pharmacies (La Habra, CA) received a form 483 at the close of inspection on October 18, 2019.
Avenue Pharmacy Inc
Avenue Pharmacy Inc (Ocala, FL) received a form 483 at the close of inspection on December 6, 2019.
Lloyd Central Compounding Pharmacy
Lloyd Central Compounding Pharmacy (Portland, OR) received a form 483 issued at the close of inspection on November 26, 2019.
McGuff Compounding Pharmacy Services Inc.
McGuff Compounding Pharmacy Services Inc. (Santa Ana, CA) received a form 483 at the close of inspection on November 22, 2019.
MPRX Inc
MPRX Inc (Dallas, TX) received a form 483 at the close of inspection on November 22, 2019.
Pharmaview, Inc.
Pharmaview, Inc. (Bedminster, NJ) received a form 483 issued at the close of inspection on November 14, 2019.
Randol Mill Pharmacy
Randol Mill Pharmacy (Arlington, TX) received a form 483 at the close of inspection on August 6, 2019.
Right Value Drug Store, Inc (dba Carie Boyd’s Prescription Shop)
Right Value Drug Store, Inc (dba Carie Boyd’s Prescription Shop) (Hurst, TX) received an untitled letter on October 25, 2019. The firm compounded drugs that were not eligible for this activity. Some products did not include complete information on the container to permit adverse event reporting. The firm did not notify the FDA which drug products they compounded as required. Further, the company distributes unapproved new drugs and misbranded drugs.
Right Value Drug Store, Inc (dba Carie Boyd’s Prescription Shop)
Right Value Drug Store, Inc (Hurst, TX) received a form 483 issued at the close of inspection on November 12, 2019.
SCA Pharmaceuticals, LLC
SCA Pharmaceuticals, LLC (Little Rock, AR) received a form 483 at the close of inspection on November 7, 2019.
Snyder Mark Drugs Roselle, Inc (dba Mark Drugs Pharmacy)
Snyder Mark Drugs Roselle, Inc (dba Mark Drugs Pharmacy) (Rochelle, IL) received a form 483 at the close of inspection on September 27, 2019.
Govzilla Store’s Most Purchased Individual 483s
483 Amgen Manufacturing Juncos Apr 2019
483 Amneal Pharmaceuticals Brookhaven Jan 2019
483 Amneal Pharmaceuticals Matoda Apr 2019
483 Choksi Labs Indore Apr 2018
483 Glenmark Pharmaceuticals Colvale Bardez Goa Sep 2013
483 Glenmark Pharmaceuticals Pithampur Dhar Feb 2016
483 Nanjing King-Friend Biochemical Pharmaceutical Nanjing Apr 2018
483 New Zealand Pharmaceutical Manawatu Wanganui May 2018
483 SGS Canada Mississauga Dec 2017
483 Teva Parenteral Manufacturing Irvine Jan 2019