Last week, FDA issued Warning Letters to two drug companies, one a repackager and the other a manufacturer of sunscreen, and two compounding pharmacies. Both drug Warning Letters cited issues with the Quality Unit while products were recalled from both compounding pharmacies.

Drug Warning and Untitled Letters

Coupler Enterprises

Coupler Enterprises (Warrington, PA) received a Warning Letter on September 15, 2020, based on the outcome of an inspection ending March 10, 2020. The firm repackages human drugs. Deficiencies include, but are not limited to:

  • The investigators noted multiple different tablets and capsules in the packaging area. Documentation indicated that the line clearance had been performed. FDA is concerned about inadequate line clearance and the possibility of product mix-ups.
  • The firm did not demonstrate that cleaning activities are sufficient to remove residues from equipment shared among drug products. The firm could provide no justification for those drug products used in cleaning validation studies. Although the firm has a consultant they could not explain progress in this area.
  • The Quality Unit did not provide adequate oversight and FDA particularly mentioned the lack of adequacy in deviation investigations. The Quality Unit also failed to see that equipment was qualified.

HNC Product

HNC Product Inc. (Bloomington, IL) received a Warning Letter on September 10, 2020, based on the outcome of an inspection ending March 17, 2020. In addition to the adulteration violations, the firm failed to meet the registration and listing requirements in the FD&C Act. The firm manufactures sunscreens. FDA notes “Your quality system does not adequately ensure the accuracy and integrity of data to support the safety, effectiveness, and quality of the drugs you manufacture.” FDA adds their short version of the boilerplate they use for data integrity remediation requirements. FDA explains that the Quality Unit does not have adequate authority to exercise its authority and responsibilities and finally suggests the firm employ a qualified consultant to assist them in coming into GMP compliance. Deficiencies include but are not limited to: 

  • OOS investigations are inadequate. The example noted that sample and standard preparation, root cause analysis conclusions, and corrective actions were missing. Further, the original data for the OOS had been overwritten (electronically) and were missing. The rationale for invalidating the result is not scientifically justified and did follow OOS procedure. 
  • Manufacturing processes were not validated, nor was there an ongoing program for review process results. 
  • The firm does not have an independent and effective Quality unit. Further, there is no change management or annual product review program. Further, bulk products are shipped outside of the firm’s control prior to receipt of final laboratory test results. 

Device Warning and Untitled Letters

There were none this week.

BIMO, GCP and GLP Warning and Untitled Letters

There were none this week.

Compounding Pharmacy / Outsourcing Facilities

First Royal Care Co LLC dba Red Mountain Compounding Pharmacy 

First Royal Care Co LLC dba Red Mountain Compounding Pharmacy (Mesa, AZ) received a Warning Letter on September 8, 2020, based on the outcome of an inspection ending June 14, 2019. FDA notes the firm agreed to recall all sterile human and animal drugs that are within expiry after the audit. In addition to adulteration violations, the firm also compounds and sells drugs the FDA deems to be misbranded.

Integrated Health Concepts Inc. dba Conversio Health

Integrated Health Concepts Inc. dba Conversio Health (San Luis Obispo, CA) received a Warning Letter on September 10, 2020, based on the outcome of an inspection ending September 25, 2019. FDA also notes the firm has recalled all sterile products within expiry three months after the end of the inspection and ceased sterile operations to permit implementation of improvement plans.

Comparing and Analyzing Russian, UK, and US Top Ten Pharma Inspection Findings FY 2019

Webinar: Comparing and Analyzing Russian, UK, and US Top Ten Pharma Inspection Findings FY 2019

Presented by Jerry Chapman on October 29, 2020

What you will learn:

  • A comparison of 483 observations in FY2019
  • Top 10 Russian Ministry of Health inspection findings
  • Top 10 FDA Warning Letter findings
  • Top MHRA inspection findings
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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

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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Champion of Change - 3Cs to Success

Webinar: Champion of Change - 3Cs to Success

Presented by Steve Greer on June 23, 2020

What you will learn:

  • The 3C Model to become a champion of change
  • How to identify game-changing habits and the steps to implement them
  • Ways to develop greater purpose-centered leadership
  • How to generate awareness along with actions to create changes in how you think about challenges and change putting you on a path to lead change successfully in your organization
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5 GMP Case Studies Report

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

 

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What You Will Learn from This Report:

How a major pharmaceutical company designed a program to train future leaders in quality

An industry-led initiative to advance the state of quality in the pharma industry

A pharma GMP leader’s tips for supporting quality culture within an organization

An update on FDA’s Quality Maturity Model

Impact of the Global Pandemic on Recent Data Integrity and Regulatory Non-compliance Trends

Webinar: Impact of the Global Pandemic on Recent Data Integrity and Regulatory Non-compliance Trends

Presented by Paul Smith, Agilent Technologies on Aug. 26, 2020

What you will learn:

  • Examples of essential laboratory actions to remain compliant during the pandemic
  • Recent data integrity non-compliance findings and trends
  • Essential strategies to find, understand, and leverage regulatory non-compliance data

Past, Present, and Future of Quality Culture

Presented by Regulatory Compliance Associates Distinguished Fellow Susan Schniepp

What you will learn:

  • How the 2014 FDA quality metrics initiative led to greater focus on quality culture
  • New quality culture tools and standards under development by PDA and other organizations
  • Best practices for quality culture, including case studies with lessons learned

Changing Medical Device Regulations

Presented by Redica Systems 

What you will learn:

  • The latest developments regarding the EU MDR
  • Quality Systems requirements for medical devices
  • Regulatory updates affecting medical devices

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Combination Product Report

What You Will Learn from This Report:

The latest U.S. and European regulatory developments

The impact of smart combination products

How the EU MDR impacts drug-device combination products

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5 GMP Case Studies Report

What You Will Learn from This Report:

In-depth analysis of the findings

Lessons learned

How companies can avoid similar shortcomings.

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Redica Systems Expert Jerry Chapman to Present at SQA Annual Meeting

Index Information Redica consolidates regulatory data in real-time on the single largest database for quality, safety, and compliance intelligence.

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Analyze & Interpret Patterns Redica instantly models the customer-specific regulatory risks, trends, and opportunities that stand to fundamentally change compliance operations.

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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
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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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