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

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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SAGENT PHARMACEUTICALS INITIATES INJECTABLE RECALL DUE TO ASEPTIC AND GMP PRACTICES (2/23/15)

Sagent Pharmaceuticals Initiates a Nationwide Voluntary Recall of Atracurium Besylate Injection, USP, 50mg/5mL and 100mg/10mL due to FDA Observations Pertaining toAseptic and GMP Practices at the Manufacturer’s Site Potentially Impacting Product Sterility Schaumburg, IL,Sagent Pharmaceuticals, Inc. announced on February 23, 2015 the voluntary nationwide recall of two … Continue reading

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Apotex Research Private Limited, Bangalore, India Receives Warning Letter (1/30/15)

During a June 23, 2014 through July 1, 2014, inspection of the Apotex Research Private Limited (ARPL) manufacturing facilities located at Plot #1 & 2, Bommasandra Ind. Area, 4th Phase, Jigani Link Road, Bangalore, India, investigators from the U.S. Food and Drug Administration … Continue reading

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NUTEK DISPOSABLES, INC ISSUES ALERT DUE TO POTENTIAL BACTERIA IN BABY WIPES (RECALL – 10/25/14)

FOR IMMEDIATE RELEASE — Oct. 25, 2014 — MCELHATTAN, PA — Nutek Disposables, Inc. of McElhattan, PA has initiated a nationwide voluntary product recall at the retail level of all lots of baby wipes that it manufactured under the brand names … Continue reading

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