FDA to Drug Compounders: Inspection Changes Coming in August | RAPS

• Recommended FDA cGMP online training courses, classes, and programs sold by SkillsPlus International Inc.

Updated October 8, 2022

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Human Drug Compounding - FDA.gov

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Read the full article: FDA to Drug Compounders: Inspection Changes Coming in August | RAPS:

"For companies that compound human drugs in accordance with section 503A of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (i.e., human drug compounders that are not registered with FDA as outsourcing facilities under section 503B), effective 1 August 2016, “FDA investigators will make a preliminary assessment of whether such entities are compounding their human drugs in accordance with certain conditions of section 503A before closing the inspection.”"

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Read the details of the FDA Notice (PDF)

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Root Cause Analysis - GMP Training
Deviation Investigation Report Writing - GMP Training
Qualstar Simulation - Advanced GMP Training That's Fun!

 

Root Cause Analysis For Better Deviation Investigations - Our Most Popular cGMP Training

Updated June 12, 2025

The referenced courses are no longer available as live workshops.

You might also be interested in the online versions of these popular training courses:

Deviation Investigations and Investigation Report Writing

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A GMP Training Workshop - Root Cause Analysis For Better Deviation Investigations

Still true after so many years . . . One of the top reasons for a company to receive a 483 is a deficiency in the deviation investigation process.

In our onsite hands-on workshop, employees learn the most effective tools to determine the real root cause of the problem. Attendees use actual plant deviations to practice the use of the tools.

This workshop is typically paired with another workshop for the best training results:
Writing Deviation Investigation Reports - A SkillsPlus Intl Inc. cGMP training workshop

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FDA FastStats: A Look Back at all FDA 483 Inspectional Observations for Fiscal Year 2014 - AssurXblog

View the chart & read the full article:  FDA FastStats: A Look Back at all FDA 483 Inspectional Observations for Fiscal Year 2014 - AssurXblog:

". . . FDA 483 Inspectional Observations for Fiscal Year 2014. 483s increased in foods from the prior fiscal year to 2476, an increase of 3.8%. However, medical devices and drugs were down -11.6% and -6.5%, respectively, from FY 2013. Interestingly, medical device 483s bucked their recent upward trend with the lowest number of observations since FY 2009."

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Dietary Supplement Firms Still Violating Basic Manufacturing Rules - NPI

Updated September 4, 2024

The original link broke.

You can still read about the same topic here, on Natural Products Insider:

https://www.naturalproductsinsider.com/manufacturing/fda-still-finds-basic-gmp-violations-in-supplement-industry

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Dietary Supplement Firms Still Violating Basic Manufacturing Rules - Natural Products Insider:

"FDA has been bringing down the hammer on one out of three dietary supplement firms for failing to comply with cGMPs. Through the first several months of fiscal year 2013, of the 350 cGMP inspections FDA originally designated and concluded as falling under Part 111, the agency's 19 district offices collectively classified 33 percent, or 117 businesses, as OAI (official action indicated)."

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FDA 483s Can Form Basis of Class Action Lawsuit

• Trusted FDA cGMP online training programs and courses offered by SkillsPlus Intl Inc.

In the long list of things that are inadvisable to regulatory professionals, making misleading statements to the authority in charge of regulating your business likely ranks near the top. Those found to have misled the U.S. Food and Drug Administration (FDA) have in the past been publicly warned, fined, imprisoned, shut down and barred from participating in federal programs.

Now KV Pharmaceuticals is facing the prospect of an additional action: a class-action shareholder lawsuit as the result of an FDA inspection report. This is an important event, and here's why . . .

Judge: Regulatory Inspection Report Can Form Basis of Class Action Lawsuit - RAPS - News - Article View:

"On Monday, 4 June a federal appeals court ruled a securities fraud class action lawsuit could proceed against pharmaceutical manufacturer KV Pharmaceuticals for purportedly causing $1.5 billion in shareholder losses after first misleading FDA about manufacturing problems at a facility and later shutting down the facility’s manufacturing operations."

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What's important to note is that this decision is a marked reversal from existing precedence, which has found Form 483 reports to be immaterial to federal securities law.

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Olympics for Medical Device Manufacturers - Onsite QSR Training Class

This class gets students engaged, energized, and so excited that they'll be up out of their seats!

Olympics for Medical Device Manufacturers - Onsite QSR Training by SkillsPlus International Inc.

This course takes QSRs to a deeper level of understanding through a series of challenging activities. Past students would say this training is fun!  This instructor led class is taught on-site in-house at client plant locations.

By the end of class, students will be able to:
1. List the hottest issues in QSR compliance.
2. Locate items of interest in 21CFR820.
3. Explain the 21CFR211 rationale for specific 483 observations.
4. Demonstrate knowledge of common CGMP practices and details.
5. State the consequences of not following QSR.

For more information, visit:
Olympics for Medical Device Manufacturers - Onsite QSR Training by SkillsPlus International Inc.

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• Essentials for Medical Device Manufacturers - Live onsite QSR training class (skillsplusinfo.blogspot.com)
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Onsite cGMP Training - Olympics for Pharmaceutical & Biotech Manufacturers

Updated June 5, 2021

Given the COVID-19 pandemic, people are also interested in:

FDA GMP Online Training - respected FDA CGMP online training courses presented by SkillsPlus International Inc.

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Onsite cGMP Training -  Olympics for Pharmaceutical & Biotech Manufacturers - by SkillsPlus International Inc.

How many boring training classes have you and your colleagues been through?!

Say NO to boring training. Experience exciting, energizing, and engaging training!

Take a deep dive to a deeper level of understanding through a series of challenging activities.

By the end of this class, energized students will be able to:
1. List the hottest issues in CGMP compliance.
2. Locate items of interest in 21CFR211.
3. Explain the 21CFR211 rationale for specific 483 observations.
4. Demonstrate knowledge of common CGMP practices and details.
5. State the consequences of not following CGMPs.

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Related articles

• Root Cause Analysis for Better Deviation Investigations - Live onsite GMP & QSR training (skillsplusinfo.blogspot.com)
• Live Onsite GMP Training - Essentials for Pharmaceutical Manufacturers (skillsplusinfo.blogspot.com)

Management Session: What Every Manager Needs to Know - GMP & QSR Training

Updated June 6, 2025

The course highlighted is no longer available. 

You might also be interested in these online GMP training courses:

https://gmpprof.com/cgmp-training-a-new-generation/

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Management Session: What Every Manager Needs to Know - is a live onsite GMP & QSR training class by SkillsPlus International Inc.   This is an instructor led course, taught on-site in-house in-plant at the locations of your choice.

Know your stuff and lead with confidence!

This course addresses CGMP and QSR issues directly relevant to the executive leadership and executive teams of manufacturers.

Upon completion of this class, you'll be able to:
1. State the common 483 observations issued by the FDA.
2. List the basic requirements of CGMP or QSRs that require the attention of the leadership team.
3. Identify gaps in compliance.
4. Identify the issues that needs to be rectified.

For more information, visit:
Management Session: What Every Manager Needs to Know - training by SkillsPlus International Inc.

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• Live Onsite GMP Training - Essentials for Pharmaceutical Manufacturers (skillsplusinfo.blogspot.com)
• Deviation Investigation Reports - Live onsite cGMP & QSR training class (skillsplusinfo.blogspot.com)
• Live Onsite GMP Training - Olympics for Pharma & Biotech Manufacturers (skillsplusinfo.blogspot.com)
• Executive Session: What Leadership Needs to Know - Onsite cGMP & QSR training (skillsplusinfo.blogspot.com)

Human Errors: Overcoming the Challenges - Onsite cGMP & QSR training

Human Errors: Overcoming the Challenges - live on-site cGMP & QSR training by SkillsPlus International Inc.

Humans make errors, AND, more likely, there are processes and systems that are root causes of setting people up to fail.

Purpose:
This class teaches how to overcome human errors as a root cause to deviations.

Objectives:  upon class completion, students will be able to . . .
1. State what the CGMPs imply regarding human errors.
2. State the FDA's current thinking about human errors and deviations.
3. Describe the basics of root cause determination.
4. List the possible root causes to human errors.

Topics Covered:

• Overview of 483 observations
• Psychology of human failures
• Investigating human errors
• Preventing human errors

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