Another busy week for FDA continuing to issue warning letters to firms who claim to diagnose or treat COVID-19. This week there were also several warning letters issued for failure to comply with the food foreign supplier verification program, the most recent Tobacco Control Act, and food production GMPs.

Among the areas we follow, there were two warning letters, one to an HCT/P manufacturer who also received a warning letter in March 2020, and one to a drug manufacturing site in India. None of those posted were issued to device firms or outsourcing facilities.

Wintac Limited

Wintac Limited (Somerset, NJ) received a warning letter on August 13, 2020, based on the outcome of an inspection at one of the firm’s sites in India ending February 19, 2020. FDA recommends the firm hire qualified consultants to assist them in coming into GMP compliance. The two well-detailed deficiencies address failures in sterility assurance. The deficiencies include, but are not limited to:

  • Inadequate investigation of contaminated media fill units. The investigation lacked a scientific justification for focus on only part of the run and ruling out other potential causes; no CAPAs were initiated, and the investigation was closed without assessing how other batches of product manufactured on that line may have been compromised. Similar investigation deficiencies were observed when the firm qualified a new filling line in June 2019.
  • The firm did not establish adequate procedures to prevent microbiological contamination of drug products. Examples include inadequate media fills that were not representative of commercial manufacture. Also, inadequate smoke studies did not include simulation of interventions and other related activities.

Banco Vida Corp

Banco Vida Corp (San Juan, Puerto Rico) received a warning letter from CBER on August 12, 2020, based on an inspection ending September 18, 2019. The firm also received a warning letter in March, 2020. The most recent warning letter documents adulteration of their cord blood products and intermediates. Deficiencies identified during the inspection include but are not limited to:

  • Failure to screen donor cells/tissue by reviewing medical records
  • Aseptic manufacturing processes not validated
  • There is no written procedure for gowning
  • Cord blood intermediate processes not validated
  • Cleaning and maintenance of equipment inadequate
  • EM and personnel monitoring not conducted during manufacture

Device Warning and Untitled Letters

No letters were issued this week. 

Letters to Compounding Pharmacies and Outsourcing Facilities

No letters were issued this week. 

BIMO, GCP and GLP Warning and Untitled Letters

No letters were issued this week. 

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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

 

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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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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

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.

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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

Get instant access to the webinar video and slides.

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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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
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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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