• Home
  • About
  • UPCOMING WEBINARS & SEMINARS
  • Consultation
  • USP 61/62 FAQ
  • Contact

Barry A. Friedman, PhD LLC

FDA Regulatory Compliance for the Pharmaceutical, Biotechnology and Medical Device Arenas

FIRM REPEATLY DECLINES TO RECALL ITS STERILE PRODUCTS

August 18, 2013 By Barry Friedman Leave a Comment

IS THIS THE NEW “POSTER CHILD” FOR NON-COMPLIANCE? On Friday, August 16, 2013 the FDA issued a News Release wherein it reminded “health care providers not to use sterile products from NuVision Pharmacy”.  The FDA indicated that the rationale behind the News Release was because the … [Read more...]

H&P’s ANATOMY OF A CONSENT DECREE (01/24/12)

February 15, 2012 By Barry Friedman 1 Comment

H&P INDUSTRIES FULFILLS ITS INITIAL OBLIGATIONS AND RECEIVES RETURNED BOND H&P Industries has a recent history of receiving significant Form FDA 483s from the FDA.  The consequence of these various recalls and 483s ultimately led to a seizure of raw materials, in-process product and final product by U.S. Marshalls.  Subsequent to that H&P Industries entered into a … [Read more...]

FDA ORDERS SEIZURE OF TRIAD PRODUCT WORTH $6 MILLION

April 7, 2011 By Barry Friedman Leave a Comment

FDA Orders Seizure Of Antiseptic, Antifungal Products Worth $6 Million The AP (4/6) reported that the Food and Drug Administration "said Wednesday that antiseptic products made by Triad Group and H&P Industries were seized to prevent the distribution of products that might be contaminated and pose a health risk." At the FDA's request, US Marshals seized more than "$6 … [Read more...]

TRIAD GROUP RAIDED BY U.S. MARSHAL SERVICE (APRIL 4, 2011)

April 5, 2011 By Barry Friedman Leave a Comment

TRIAD GROUP RAIDED BY U.S. MARSHAL SERVICE (APRIL 4, 2011)  See also new FDA-483 from March 28, 2011 (Link attached below) HARTLAND, Wis.— A medical products maker in Hartland ceased production Monday after the U.S. Marshals Service arrived to quarantine or seize materials.  The Milwaukee Journal Sentinel reports H&P Industries, which makes alcohol wipes and other … [Read more...]

New Reader? Learn More

Connect With Me:

  • Email
  • Facebook
  • LinkedIn
  • RSS
  • Twitter

Subscribe to Blog via Email

Enter your email address to subscribe to this blog and receive notifications of new posts by email.

Webinar Registration & Information

FREQUENTLY ASKED QUESTIONS:

FDA Form 483 Frequently Asked Questions

USP General Chapter

USP General Chapter 62, Part II

TOP OBSERVATIONS:

FDA’s CDER LISTING OF TOP NINETEEN OBSERVATIONS FOR 2014

FDA CDER Most Frequent Form FDA 483 Observations Fiscal Year 2012

CDER MOST FREQUENTLY CITED DRUG OBSERVATIONS – FISCAL YEAR 2010

Top Posts:

Top Posts for 2012

Top Posts for 2013

Top Posts Year To Date

Recent Posts

  • Upcoming Microbiological Webinars
  • Microbiological Webinars
  • Microbiological Webinars 2020 (Upcoming)
  • General Chapter (USP<60>) on B. cepacia Complex to Issue December 1, 2019
  • Les Produits Chimiques B.G.R., Inc. Receives FDA Warning Letter (07/24/2018) for Failure to Perform Laboratory Testing

Categories

follow us in feedly
  • Home
  • About
  • UPCOMING WEBINARS & SEMINARS
  • Consultation
  • USP 61/62 FAQ
  • Contact
  • Email
  • Facebook
  • LinkedIn
  • RSS
  • Twitter

Thank You For Visiting Barry A. Friedman, PhD LLC - 2015

Welcome To My Blog!
Please enter your name and email below to receive my newsletter.
Your information will *never* be shared or sold to a 3rd party.