It was a busy week on the warning letter front with one warning letter issued to an HCT/P firm and three issued to OTC manufacturers located outside the US. Along with these warning letters which we cover below, the Center for Tobacco Products cited Smart Toothpicks, LLC in Tempe, AZ, for sale of dissolvable nicotine infused toothpicks based on information from their website.

DRUG | Baha Fur S.A. de C.V

Baha Fur S.A. de C.V (Tijuana, Mexico) received a warning letter on December 13, 2019, based on the outcome of an inspection ending July 12, 2019. The warning letter was sent to the CEO in the City of Industry, CA regarding this site. The firm manufactures OTC products. FDA advises the firm to hire a qualified consultant to assist them in coming into compliance.

Deficiencies include but are not limited to:

  • The firm did not adequately investigate microbiological test results that were OOS. Even though the lot(s) were rejected, the firm should have conducted an investigation to identify the root cause and implement corrective actions to prevent this from happening in the future. The incubation parameters for microbiological tests performed at the contract laboratory differ from USP<61>. FDA also deems the firm’s response inadequate because the investigation did not consider distributed products that may be impacted by microbiological contamination.
  • Batch records lack adequate detail including, for example, identification of each step in the filling operation and identification of the person who performed each significant step. The firm’s response was deemed inadequate because the firm did not provide details of how they would confirm compliance with batch records or other control records. Further, it did not provide information regarding review, evaluation, or identification of significant process parameters that apply to the drug product packaging and labeling operations.
  • The firm did not adequately validate cleaning procedures for shared equipment. The cleaning is inadequate to prevent cross-contamination among products. The response to the observation was inadequate because it failed to determine the risk of potential cross-contamination and its impact on product quality for marketed products.

DRUG, HCT/P | R & B Medical Group Inc

R & B Medical Group Inc (Van Nuys, CA) received a warning letter on January 15, 2020, based on the outcome of an inspection ending September 25, 2019. The firm is a contract testing laboratory that tests for communicable diseases for fertility clinics and medical practices. Their data is used to determine donor acceptability for oocytes and semen. Thus, they are governed by 21 CFR 1271.

Deficiencies identified include but are not limited to the following:

  • Donor screening tests were not used consistent with manufacturer’s instructions nor were all data, particularly data that were positive for a communicable disease, reported to the firm providing the sample. Screening test results are not reported, but only confirmatory or additional test results are communicated. In addition, samples were stored longer than allowed by the test kit manufacturer’s instructions.
  • The firm has not “established and maintained” procedures for all steps they perform. FDA says that “Establish and Maintain” means “define, document, and implement; then follow, review and…revise on an ongoing basis.” The firm has failed to develop procedures for, among other activities, documentation of test kit numbers, identification of equipment used during testing, incubation times, steps in reporting results to clients, and calibration/maintenance of testing equipment.
  • The firm does not have procedures to complain about management and their investigation.
  • The firm does not have a quality program that includes investigation and documentation of deviations.
  • The FDA investigators identified numerous incomplete records, missing documentation of lot number, and missing documentation of who performed the test.
  • The agency expressed concern about the representation of screening test results as negative after performing confirmatory tests. The confirmatory test may not be as sensitive as screening tests. Note that within deficiency #1 the firm does not communicate the screening results which were positive for disease detection if the confirmation test was negative.

DRUG | Dental-Kosmetik GmbH & Co. KG

Dental-Kosmetik GmbH & Co. KG (Dresden, Germany) received a warning letter on January 16, 2020, based on the outcome of an inspection ending July 19, 2019. The firm’s products contain glycerin and FDA is concerned they may not be adequately tested for diethylene glycol. FDA also states that the firm’s quality systems are inadequate, and they should engage a consultant to assist them in coming into GMP compliance. FDA also placed the firm on Import Alert on January 10, 2020. The firm manufactures OTC drug products.

Deficiencies include but are not limited to:

  • The firm has not validated their manufacturing process and states that “due to the variability the production process cannot be validated…” FDA found that unacceptable and justifies why process validation is important.
  • While the deficiency is well redacted it appears that the firm’s water system is not adequately designed, controlled, maintained, and monitored.
  • The stability program is not adequate to ensure the product meets specifications through their labeled expiry period. There are no long-term data; the only batch on stability is an R&D batch and what appears to be one commercial batch.
  • The firm did not test incoming API for identity, purity, or other quality attributes, nor have they established the reliability of the results on the vendor’s certificate of analysis. The firm relies on the CoA to verify identity.

DRUG | Sunstar Guangzhou Ltd

Sunstar Guangzhou Ltd (China) received a warning letter on January 22, 2020, based on the outcome of an inspection ending June 28, 2019. The firm manufactures OTC drug products. FDA placed the firm on Import Alert on January 21, 2020. FDA recommends the firm engage a qualified consultant to assist them in coming into compliance with GMPs. FDA also has concerns about whether glycerin used by the firm is adequately tested for diethylene glycol.

Deficiencies include but are not limited to the following:

  • The firm released some drug products without testing for the identity and strength of the active ingredient. The firm’s response was inadequate because they did not test reserve samples to ensure they met specifications for identity and strength.
  • The firm does not test incoming products to confirm their identity, including the active ingredients.
  • The firm does not consistently perform growth promotion testing on the in-house media prepared by microbiological testing.
  • The quality unit does not have adequate procedures and does not provide adequate oversight over manufacturing operations. The firm does not have adequate control over the issuance, use, and reconciliation of manufacturing batch records and equipment maintenance sheets; raw data for laboratory test standard curves could not be located; scrap paper was used to record data; uncontrolled copies of batch records were pre-printed and maintained in an unsecured location.

Download the Special 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

 

Download the Special Report

CDMO Comparison opt-in

In this summary we identify:

FY2018-FY2020 GMP data for Lonza & Catalent

Top GMP primary citations

Top FDA 483 observations

Redica Systems Enforcement Analytics

Prepare for your next inspection.

Enter your email address and someone will contact you shortly to explore enforcement trends. 

Redica Systems Enforcement Analytics

Prepare for your next inspection.

Enter your email address and someone will contact you shortly to explore observations and trends. 

Redica Systems Enforcement Analytics

Prepare for your next inspection.

Enter your email address and someone will contact you shortly to run your custom report.

Redica Systems Enforcement Analytics

Get help choosing the right CRO.

Enter your email address and someone will contact you shortly to customize your insights.

Redica Systems Enforcement Analytics

Compare two companies of your choice.

Enter your email address and someone will contact you shortly to customize your report.

Download the Special Report

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

Panel Discussion opt in image

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.

Redica Systems Enforcement Analytics

Monitor compliance at your Clinical Investigator sites.

Enter your email address and someone will contact you shortly to get you started.

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
Redica Systems Enforcement Analytics

Get Full Access to Redica Enforcement Analytics

Enter your email address and someone will contact you shortly to answer all of your questions and get you started.

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

Download the Special Report

APAC ad

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

Download the Special Report

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

Experience the Power of Redica Systems

Redica Pro Free

Sign up for your FREE account today and get instant access to:

SEARCH Find the inspection records you want by inspector’s name, company name, site, city, country, etc.

WARNING LETTERS Easily search the largest database of FDA Warning Letters by date, company, FDA office, or subject

SITES Quickly assess inspection records including dates and inspectors across all of your sites

INSPECTIONS Complete list of FDA inspections by date, company, category, and country

Get Complete Access to the Redica Systems Platform

Please submit your email address and one of our team members will contact you shortly to answer all of your questions and get you started with the new Enforcement Analytics platform.

Redica Systems Enforcement Analytics

Prepare for inspections of Clinical Investigator sites.

Enter your email address and someone will contact you shortly to provide more Clinical Investigator data about your sites.

Redica Systems Enforcement Analytics

Compare the enforcement history of your CDMOs.

Enter your email address and someone will contact you shortly to customize your report.

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
Redica Systems Enforcement Analytics

See how we can help you eliminate yet another spreadsheet.

Enter your email address and someone will contact you shortly. 

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
  •  

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

Experience the Power of Redica Systems

Redica Systems Enforcement Analytics

Let us know who you are and we’ll be in touch to answer all of your questions and get you started.

Redica Systems Enforcement Analytics

Keep up with the latest Regulatory Developments on Clinical Trials

Enter your email address and someone will contact you shortly. 

Redica Systems Enforcement Analytics

Save your team valuable time when using External Monitoring.

Enter your email address and someone will contact you shortly. 

Redica Systems Enforcement Analytics

Save time and Resources when using External Monitoring.

Enter your email address and someone will contact you shortly. 

Redica Systems Enforcement Analytics

Get immediate access to the news that matters to your sites.

Enter your email address and someone will contact you shortly. 

Redica Systems Enforcement Analytics

Stay ahead of changing regulations.

Enter your email address and someone will contact you shortly to get the data and analysis you need.

Redica Systems Enforcement Analytics

Compare the inspection history of your CDMO sites.

Enter your email address and someone will contact you shortly to customize your report.

Redica Systems Enforcement Analytics

Upgrade your CDMO monitoring strategy.

Enter your email address and someone will contact you shortly to get the data and analysis you need.

Redica Systems Enforcement Analytics

Upgrade your CDMO management strategy.

Enter your email address and someone will contact you shortly to get the reports and analysis you need.

Experience the Power of Redica Systems

Redica Systems Enforcement Analytics

Sign up for your FREE account today and get instant access to Enforcement Analytics.

Redica Systems Enforcement Analytics

Upgrade your inspection strategy.

Enter your email address and someone will contact you shortly to get the reports and analysis you need.

Redica Systems Enforcement Analytics

Upgrade your inspection strategy.

Enter your email address and someone will contact you shortly to get the reports and analysis you need to prepare for your next inspection.

Experience the Power of Redica Systems

Complete the form and one of our experts will reach out to you to schedule a demo and answer questions about our subscription options.

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

STRENGTHEN DATASETS Redica machine intelligence algorithms identify and triage risk signals to derive meaning from vast amounts of private and public data.

ANALYZE & INTERPRET PATTERNS Redica instantly models the customer-specific regulatory risks, trends, and opportunities that stand to fundamentally change compliance operations.

Redica Systems Enforcement Analytics

Evaluate Your CDMOs

Enter your email address and someone will contact you shortly to customize your report.

Discover the power of the most comprehensive database of 483s in existence.

Our database of over 20,000 483s is retyped and tagged, making it easy to create an Observation Report in seconds.

Eliminate days of work and get your FREE personalized 483 Observation Report.