January 483s: Most Popular and Newsworthy

In January, FDA posted 12 Form 483s and one untitled letter to compounding/outsourcing facilities.  We list them below.

And, we reviewed the Govzilla Store to see which 483s were most-purchased and trending during January.

[NOTE: Are you interested in learning more about observations with specific industry keywords? Get your FREE 483 Observation Report and you can quickly determine who has been hit with the same observations. Learn more here!]

Govzilla 483 Observation CTA

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 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

483 Valley Processing Sunnyside Jun 2019

483 WuXi AppTec Saint Paul Sep 2019

[NOTE: With a 483 Observation Report, you can quickly determine if there’s a citation trend you should be aware of.  Learn more here!]

Govzilla 483 Observation CTA

Learn how Govzilla can help you achieve your quality and inspection preparation goals:
483s
InspectorProfiles
Enforcement Analytics
GMP Regulatory Intelligence

Contact us if you ever have questions at [email protected].

Like this post? Don't forget to share it!

Share on facebook
Share on twitter
Share on linkedin
Share on email
Share on print
Govzilla Bug

Don’t miss out! Subscribe now

Experience the Power of Govzilla

Get your FREE account to search sites, inspections, & warning letters