This week FDA posted one warning letter to a drug firm and two to compounding pharmacies. One compounding pharmacy received a warning letter from an inspection ending in 2018, and we include the 10-observation form 483.

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Drug Warning and Untitled Letters

Homeocare Laboratories Inc

Homeocare Laboratories Inc (Yonkers, NY) received a warning letter on June 22, 2020, based on the outcome of an inspection ending December 13, 2019. The firm manufactures OTC drug products including some using potent components including progesterone, Belladonna, Aconitum Napellus, and Arsenicum album. FDA recommends the firm hire a qualified consultant to help them resolve their deficiencies. Further, the warning letter identifies unapproved new drug violations.

Deficiencies include but are not limited to:

  • The firm releases drug products without testing for identity, strength, content uniformity, or impurities. The firm responded that they no longer manufacture OTC drugs and would continue to monitor the stability of drugs in distribution for “odor, appearance, and micros.”

  • The firm did not qualify suppliers, nor did they test incoming raw materials and components. All were accepted on the supplier CoA. The firm committed to audit one of the suppliers and employ a third-party laboratory to test components for identity. FDA did not accept this approach. The firm also said in their response to the 483 that vendor surveys were completed and acceptable but during the inspection, the firm stated that vendors did not complete the survey and thus the firm was using components from unapproved vendors.

  • The firm failed to validate cleaning procedures. This is particularly important because potent products are manufactured using shared equipment. The firm noted they no longer produce OTC drugs, but they do continue to manufacture homeopathic drugs. FDA did not accept their response because cleaning of shared equipment when manufacture uses potentially hazardous components remains an issue.

  • The manufacturing processes of OTC drugs are not validated.

Device Warning and Untitled Letters

No letters were issued this week. 

Letters to Compounding Pharmacies and Outsourcing Facilities

Auro Pharmacies, Inc

Auro Pharmacies, Inc, dba Central Drugs Compounding Pharmacy (LaHabra, CA) received a warning letter on June 3, 2020, based on the outcome of an inspection ending August 2, 2018 (yes, that’s not a typo, and here’s the 10-observation form 483.)  The warning letter cites the adulteration of drugs, distribution of unapproved new drugs, and misbranded drug products. The complete trifecta!

Malanda, Inc dba Mandell’s Clinical Pharmacy

Malanda, Inc dba Mandell’s Clinical Pharmacy (Somerset, NJ) received a warning letter on June 9, 2020, based on the outcome of an inspection ending July 25, 2019.

BIMO, GCP and GLP Warning and Untitled Letters

No letters were issued this week. 

Changing Medical Device Regulations

Presented by Redica Systems 

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

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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:

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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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  • 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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Combination Product Report

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The latest U.S. and European regulatory developments

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5 GMP Case Studies Report

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Redica Systems Expert Jerry Chapman to Present at SQA Annual Meeting

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5 GMP Case Studies Report

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The first countrywide import alert issued by FDA

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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

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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