Author Archives: Barry A. Friedman, PhD LLC

About Barry A. Friedman, PhD LLC

Regulatory Compliance, Expert Witness, Pharmaceuticals, Biotechnology, Aseptic Processing, GMP, GLP, Quality Control, Positron Emission Tomography (PET), Microbiology, Process Validation, Validation of Analytical and Microbiological Methods

2015 United States Pharmacopeia (USP) Microbiological General and Information Chapters Training Program

7-Part Live Training Program Starts September 30, 2015 Instructor: Barry A. Friedman Ph.D. Biography>>> Click Here to Learn More and to Register for this Live Training Program The United States Pharmacopeia (USP) contains a number of chapters relating to microbiology within its … Continue reading

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VUAB PHARMA, CZECH REPUBLIC, RECEIVES WARNING LETTER (MAY 27, 2015, con’t)

Objectionable Bacillus spp. Found During Customer Sampling  During the FDA’s inspection of VUAB Pharma a.s., Vltayska 53, Roztoky, Czech Republic, from June 09, 2014, through June 13, 2014, an investigator from the U.S. Food and Drug Administration (FDA) identified significant … Continue reading

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VUAB PHARMA, CZECH REPUBLIC, RECEIVES WARNING LETTER (MAY 27, 2015)

Objectionable Anaerobe Found During Customer Sampling During the FDA’s inspection of VUAB Pharma a.s., Vltayska 53, Roztoky, Czech Republic, from June 09, 2014, through June 13, 2014, an investigator from the U.S. Food and Drug Administration (FDA) identified significant deviations … Continue reading

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INSPECTION TRACKER: DRUG MANUFACTURING ESTABLISHMENTS (CANADA)

  Health Canada Begins Publishing Information Regarding Emerging Issues As part of Health Canada’s ongoing commitment to openness and transparency, the Department recently began publishing information regarding emerging issues identified through the drug inspection program. This tracker provides a snapshot … Continue reading

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Sagent Pharmaceuticals Recall due to FDA Observations Pertaining to Aseptic and GMP Practices at the Manufacturer’s Site Potentially Impacting Product Sterility

Sagent Pharmaceuticals, Inc. Schaumburg, IL announced on February 23, 2015 the voluntary nationwide recall of two lots of Atracurium Besylate Injection, USP, 50mg/5mL single-dose vials (NDC 25021-659-05) and four lots of Atracurium Besylate Injection, USP, 100mg/10mL multi-dose vials (NDC 25021-672-10) manufactured by Emcure Pharmaceuticals Ltd. and distributed by Sagent. Sagent has … Continue reading

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2015 United States Pharmacopeia (USP) Microbiological Training Program — 9-Part Live Training Program Instructor: Barry A. Friedman Ph.D.

STARTS THURSDAY, MARCH 19, 2015 The United States Pharmacopeia (USP) contains a number of chapters relating to microbiology within its General and General Information Chapters. These Chapters present information that relate to both non-sterile and aseptic processing. Several of these … Continue reading

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MICRO LABS LIMITED, VERNA, INDIA RECEIVES WARNING LETTER (01/09/15)

The FDA inspected Micro Labs Limited, located at Plot No. S-155 to S-159, Phase III, Verna Industrial Estate, Verna, India, between May 5-10 and 12-13, 2014. Investigators from the U.S. Food and Drug Administration (FDA) identified significant violations of current … Continue reading

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