CGMP Consulting, Inc.

06/05/2026

The cGMP Consulting team had a fantastic time at our Summer Picnic yesterday evening! It was a beautiful, sunny day filled with delicious food, fun games, and great company. From co****le and spikeball to badminton, there was plenty of friendly competition and laughter. A big thank you to everyone who joined us and helped make it such a memorable event!

06/03/2026

Non-conformance/Deviation, CAPA and Change control are three tools every quality team needs and can be confusing for those new to Quality Management Systems.

Our latest article breaks down what each one does, when to use it, and how they work together in a GMP-compliant Quality Management System. We also answer the questions we hear most often from teams building or strengthening their QMS programs.

This is a practical resource worth bookmarking.

Read the full article:

Learn the differences between non-conformances, CAPA, and change control in GMP quality systems.

06/02/2026

Continuing our FDA Form 483 series: Drugs.

Drug manufacturing saw 713 observations in FY2025, a 27% jump from 561 in FY2024. That's the highest drug sector total in three years.



So what is FDA finding most often? The top 5 citation categories are shown in this graphic.

1. Written procedures not followed (21 CFR 211.22(d)) — 243 observations

2. Investigations of discrepancies and failures (21 CFR 211.192) — 164 observations

3. Absence of written procedures (21 CFR 211.100(a)) — 162 observations

4. Laboratory controls not scientifically sound (21 CFR 211.160(b)) — 121 observations

5. Cleaning, sanitizing and maintenance (21 CFR 211.67(a)) — 95 observations



Two of the top three citations are about written procedures. Either they don't exist, or they aren't being followed.

It’s not uncommon for facilities to invest in equipment and processes but underinvest in the quality systems that document and govern them.

https://cgmpconsulting.com/services/regulatory-response/

05/29/2026

The FDA has released new guidance on responding to Form 483 observations at the conclusion of a drug cGMP inspection and it's worth a careful read.

Recently, we have shared Form 483 trends the top observations across industries. This guidance formalizes what the Agency expects from manufacturers when observations are issued: timely, substantive responses that demonstrate genuine understanding of the underlying issue.

Key takeaways:
• The FDA distinguishes between responses that acknowledge an observation and those that demonstrate corrective action with adequate supporting evidence
• Vague commitments to update procedures are unlikely to satisfy reviewers
• Root cause analysis and implementation timelines carry significant weight

This guidance warrants a full read from your quality and regulatory teams.

05/27/2026

Continuing our FDA Form 483 series: Biologics.

Of all the sectors we're covering, biologics had the most dramatic change in FY2025. Observations jumped from 49 to 110, a 124% increase in a single year.

So what is FDA finding? The graphic shows the five most common observations.
1. SOP compliance (21 CFR 606.100(b)) — 38 observations
2. Required records (21 CFR 606.160(b)) — 19 observations
3. Thorough investigations (21 CFR 606.100(c)) — 18 observations
4. Concurrent documentation (21 CFR 606.160(a)(1)) — 16 observations
5. Emergency transfusion records (21 CFR 606.151(e)) — 14 observations

Notice that each of these is a documentation or recordkeeping failure. FDA inspectors are consistently finding that the paperwork isn't keeping pace with the complex science of this industry.

https://cgmpconsulting.com/services/regulatory-response/

05/25/2026

Honoring the fallen this Memorial Day.

We are grateful for the courage and sacrifice of those who gave their lives in service to our country.

05/22/2026

The FDA issued 4,862 Form 483s in FY2025, a 20% jump from 2024.

Over the coming weeks, we'll break down top observations by industry. We recently covered Foods (specifically dietary supplements, which falls under this category), the most-cited industry by a wide margin.

cGMP Consulting has helped countless clients prepare 483 responses and remediate observations, both onsite and remotely.

Learn more about our regulatory response services: https://cgmpconsulting.com/services/regulatory-response/

For context: a Form 483 is an FDA inspector's written notice of observed violations. How a company responds, and how quickly, can mean the difference between closure and escalation to a Warning Letter.

05/20/2026

High-performing teams are built when fit, culture, and expertise align.
▪️ Fit ensures the right people are on the right challenges
▪️Culture empowers people to perform at their best together
▪️Expertise delivers the technical depth required

When these three elements come together, they deliver consistent, measurable results.

At cGMP Consulting, this is where we operate.

05/19/2026

Audits, regulatory advice, and training supported by proven expertise.

Let us help you stay ahead of regulatory challenges and achieve quality and compliance that meets your organization’s goals and objectives.

Learn more here: https://cgmpconsulting.com/services/quality-compliance/

05/15/2026

A Form 483 costs more than you think. Here is the real impact and how to prevent it.

See our latest graphic.