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Barry A. Friedman, PhD LLC

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

Microbiological Webinars

May 11, 2020 By Barry Friedman Leave a Comment

Enclosed are a series of upcoming microbiological related webinars which are being offered between now and the middle of June.  While many of us are working from home or in the office on a limited basis, this represents a great opportunity to either gain new skills or refresh those that may require refreshing.  Just click on the title of each webinar to gain … [Read more...]

FDA advises consumers not to use Blissful Remedies kratom products due to bacterial contamination 7/05/2018

July 8, 2018 By Barry Friedman Leave a Comment

 FDA  advises consumers not to use Blissful Remedies kratom products due to bacterial contamination.  The products are sold by World Organix LLC, Las Vegas, Nevada.  FDA laboratory analysis found that the products are contaminated with high counts of various bacteria that can cause infections, including Salmonella, Clostridium difficile, Klebsiella pneumoniae and Pseudomonas … [Read more...]

Burkholderia cepacia Contamination Creates Recall Situation (08082017)

August 11, 2017 By Barry Friedman Leave a Comment

FDA advises health care professionals and patients not to use any liquid drug products manufactured by PharmaTech and distributed by Rugby Laboratories and possibly other companies CDC lab testing detects product contamination, links products to patient infections [8/8/2017] FDA is advising health care professionals and patients not to use any liquid product … [Read more...]

Hospira Issues a Voluntary Nationwide Recall For Multiple Injectable Lots For Potential Lack Of Sterility Assurance (06/15/17)

June 19, 2017 By Barry Friedman Leave a Comment

 Hospira, Inc., a Pfizer company, is voluntarily recalling 42 lots of 8.4% Sodium Bicarbonate Injection, USP, 50 mL vials, 5 lots of NeutTM (Sodium Bicarbonate 4% additive solution) 5 mL vials, 5 lots of QUELICINTM (Succinylcholine Chloride Injection, USP) 200 mg/10 mL vials and 7 lots of Potassium Phosphates Injection, USP, 45 mM vials to the hospital/retail level due to … [Read more...]

Bacterial Contamination (B. cepacia) Leads to Product Recall

August 12, 2016 By Barry Friedman Leave a Comment

PharmaTech LLC Issues Voluntary Nationwide Recall of Diocto Liquid Distributed by Rugby Laboratories Due to Product Contamination For Immediate Release July 15, 2016 Contact Consumers Rugby®'s Customer Support Department 1-800-645-2158 Media Brett Ludwig (215) 970-0153 Announcement View Product Photos PharmaTech LLC of Davie, FL, the … [Read more...]

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FREQUENTLY ASKED QUESTIONS:

FDA Form 483 Frequently Asked Questions

USP General Chapter

USP General Chapter 62, Part II

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FDA’s CDER LISTING OF TOP NINETEEN OBSERVATIONS FOR 2014

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CDER MOST FREQUENTLY CITED DRUG OBSERVATIONS – FISCAL YEAR 2010

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  • 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

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