This week we cover three warning letters: two to pharma firms and one to a clinical investigator.

DRUG | Health Pharma USA LLC

Health Pharma USA LLC (Rahway, NJ) received a warning letter on Dec 18, 2019 based on the outcome of an inspection ending June 3, 2019.  The FDA reminds them that as a contract manufacturer they are responsible for the quality of drugs they produce and points them to the FDA guidance on the topic.  FDA recommends they hire a qualified consultant to assist them in coming into GMP compliance. FDA also stated, “Your firm’s quality systems are inadequate.”

Deficiencies include but are not limited to the following:

  • The first deficiency states that the Quality Unit failed to adequately exercise their responsibilities because they lacked written procedures for many of their functions, products were shipped before Quality Unit review, and they failed to implement an adequate stability program, just to name a few.
  • Batch records are missing critical information including, but not limited to, information regarding details on the tablet coating process, length of time that bulk material is blended, information on shipping boxes, lining, and labels.
  • Process validation is not adequate because there are no procedures for process validation nor are impurities and content uniformity, for example, considered to be critical drug attributes. 
  • The firm does not routinely perform identity testing for incoming components such as excipients or APIs.  Further, the firm does not adequately qualify suppliers to establish the reliability of the CoA.

DRUG | Hualan Zongheng Bio-Tech Co., Ltd

Hualan Zongheng Bio-Tech Co., Ltd (China) received a warning letter on January 9, 2020 based on the outcome of an inspection ending July 5, 2019.  The firm manufactures OTC products and was placed on Import Alert 66-40 on November 8, 2019.  FDA recommended that the firm hire qualified consultants to assist them in coming into GMP compliance.  The firm is a contract manufacturer and FDA reminded them of their responsibilities in this area.  And finally, FDA expressed concerns about whether they are adequately testing the glycerin they use as an ingredient for the presence of diethylene glycol per FDA guidance.

Specific deficiencies include but are not limited to:

  • OTC products intended for use by children were released without testing for identity and strength of the active ingredient.
  • Incoming components including APIs were not tested for identity.  The firm’s response did not commit to perform identity testing of all components used in the manufacture of drug product.  Further, the firm did not test their retain samples to ensure they meet a specification for identity.
  • The firm did not have a sufficient stability program to support the labeled 36-month expiry dating.  While the firm claimed to have stability data for “one identical drug product formula for another market” they did not provide these data to FDA in their response nor did they provide any data for their other product formulas.
  • The firm failed to validate any, except for one product, manufacturing process.  The firm makes multiple products with multiple formulations.  In their response to the form 483, the firm failed to commit to validating the manufacturing process of ALL drug products.
  • The firm has not adequately qualified the equipment used in the manufacture of drug product to ensure it operates consistently.  This deficiency is well redacted, but I think they are referring to the system for generation and distribution of water used in manufacture.

CLINICAL INVESTIGATOR | James Findling MD

James Findling MD (Milwaukee, WI) received a warning letter on December 31, 2019 based on the outcome of an inspection ending August 2, 2019.  This inspection was conducted as part of FDA’s Bioresearch Monitoring Program.

Deficiencies include but are not limited to:

  • Failure to conduct the study consistent with the clinical protocol.  The warning letter provides a litany of examples where the investigator failed to follow the protocol.

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In-depth analysis of the findings

Lessons learned

How companies can avoid similar shortcomings.

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Download your copy of THE FDA INSPECTION LANDSCAPE IN MID-2020 AND A LOOK AT VIRTUAL INSPECTION

In this summary we identify:

  • Trend analysis of FDA inspections through mid-2020
  • Strategies for preparing and hosting virtual inspections
  • New technologies to support remote inspections
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In this summary we identify:

FY2018-FY2020 GMP data for Lonza & Catalent

Top GMP primary citations

Top FDA 483 observations

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Panel Discussion – Remote Audits

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Featuring Panelists:
—Barbara W. Unger, Unger Consulting, Inc.
—Jerry Chapman, Redica Systems
—Stephanie Gaulding, Pharmatech Associates

Who Will Benefit?
This session will be valuable to GMP quality, regulatory, compliance, and management personnel in FDA-regulated industries who want to have a conversation on remote audits and get to know what is going on in the industry.

Turning Failure into Success

Presented on Tuesday, April 27, 2021 by Steve Greer, Executive Coach, Genesis Assist, and former Quality Leader, Procter and Gamble

What you will learn:

  • How to use the Leadership SOS Model to transform quality culture
  • How to strengthen quality systems to eliminate human error
  • How to generate ideas on how to set your organization up for success for shareholders, FDA, and staff
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Quality Management Systems for Small Pharma and Biotech Firms

Webinar: QMS for Small Pharma and Biotech Firms

Presented by Fenton Fong, Founder, Managing Director, & Principal at xCellarate

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What you will learn:

  • Common challenges small pharma firms face when developing a QMS
    Recent enforcement trends involving the Quality Unit
    Impact of the COVID-19 pandemic

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In this summary we identify:

GMP data from FY2017 to FY2020 for the Asia-Pacific region

Top 3 GMP primary and secondary citations

Top 3 483 observations

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An Analysis Of MHRA’s Latest Annual GMP Inspection Deficiencies Report

In this summary we identify:

  • Data from 2019 UK MHRA Inspections
  • Trends from 2015, 2016, 2018, and 2019 inspections
  • Conclusions drawn from an analysis of drug inspection data

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What You Will Learn from This Report:

The first countrywide import alert issued by FDA

An inadequate deviation investigation

An inadequate product specifications and a product recall

Process validation issues at a CMO

A different perspective on process validation and the culpability of the quality unit

 

A.I. for Quality and Compliance Teams

August 3 webinar

Presented by Redica Systems Senior GMP Quality Expert Jerry Chapman

What you will learn:

  • A basic understanding of data sources, machine learning, NLP, and A.I. tools
  • Building and applying Expert Models
  • Two case studies, one on sterile manufacturing/503B and one on data integrity

Get the scoop on recent data integrity 483 observations!

  • FY 2020 Data Integrity 483 Observations
  • Data Integrity Observations for Human Drugs
  • Observations Falling Under GMP
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Human Factors – Compliance and Applications

June webinar

Presented by Alison Sathe, Founder, Regulatory Mark & Valerie Fenster, Director of Insights and  Human Factors, Kaleidoscope Innovation 

What you will learn:

  • Human factors strategies from simple drug products to complex surgical devices
  • Primary and secondary labeling development and evaluation for usability
  • Human factors activities from product development to post-market
  • International strategies: expectations for human factors in regulatory submissions in international markets

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