Inspections News and Articles Archives

Join Lachman Consultants (Ireland) at the PDA Ireland Event: Contract Manufacturing – Achieving & Maintaining a Successful Partnership, Cork, 29th Feb.

By Webmaster Lachman and Martha Ni Chuanaigh Feb 21, 2024 Compliance Inspections News Nitrosamines Quality issues

The one-day event will explore how to achieve and maintain good relationships with your Contract Manufacturer Organisation (CMO) Partners. Key industry leaders will share their perspectives on many topics such as the selection of a service provider, regulatory trends, and how to foster collaborative synergies when outsourcing. Lachman Consultants (Ireland) provides a full range of […]

Nov

A New Approach to cGMP Inspections is Coming Soon. Our Contract Pharma Article Gives You a Preview.

By Matt Taylor Nov 10, 2023 Biosimilars cGMPs FDA Guidance Inspections Regulatory Affairs

Earlier this year, the FDA issued a draft Guidance for Industry titled “Alternative Tools: Assessing Drug Manufacturing Facilities Identified in Pending Applications Guidance for Industry.” The proposed Guidance uses a risk-based approach based on product quality or facility-related risks and will be determined on a case-by-case basis by the FDA. Are you among the many […]

Sep

Is your company suitably staffed? Our article in Contract Pharma takes this issue head on.

By Matt Taylor Sep 01, 2023 FDA Inspections Quality issues Staffing

According to reports, the pharmaceutical job market has been expanding exponentially in recent months and is on an upward trajectory for job seekers. Occupational profiles are changing and many existing jobs, as a result of automation, are evolving, while completely new jobs are emerging. In this post-pandemic growth period, pharmaceutical companies are beginning to recognize […]

Aug

Mock-Inspection-Blog-image-Lachman-Consultants

5 Reasons Why You Should Perform a Mock Inspection Now

By Binh Nguyen and Matt Taylor Aug 24, 2023 Biologics Data Integrity FDA Generics Inspections Medical Devices Pharmaceutical industry

As U.S. consumers are facing critical drug shortages, leading Congress to question the FDA’s foreign inspection program, particularly for products with supply chains from India and China, the oversight of CGMP inspections is high on the Agency’s radar. With approximately 32% of generic drugs and 45% of active pharmaceutical ingredients (APIs) from these two countries, […]

Aug

Is Your Company “Inspection Ready?” Our article in Contract Pharma will help you be better prepared.

By Matt Taylor Aug 10, 2023 FDA Inspections

It has been more than a year-and-a-half since the FDA released its publication “An update to the Resiliency Roadmap for FDA Inspections.” Are you among the many companies wanting to stay current and who can benefit from some assistance in creating an executable year-to-year plan to maintain both long and short-term inspection proactivity? If so, […]

May

Ready for an FDA Inspection? Be prepared. Read our Contract Pharma article.

By Webmaster Lachman May 05, 2023 FDA Inspections Investigations Uncategorized

Being proactive is always better than being reactive. And when it comes to a possible “visit” from FDA, anticipation and preparation go a long way in lowering anxiety and navigating the process successfully. Knock, knock. When an FDA investigator walks into your facility informing that they are going to conduct an inspection, a tense moment […]

Feb

FDA 2023 Inspection Roadmap, Is “Readiness” in Your Annual Objectives?

By Patrick Day Feb 03, 2023 Compliance FDA Inspections

The FDA exhibits a high degree of transparency in projecting its intentions and inspection plans. One has only to look at publications such as, “An update to the Resiliency Roadmap for FDA Inspections” (here) that was issued November 2021. So, one may ask, what has happened in the meantime and what is the plan for […]

Jul

How to Prepare for an FDA Inspection – Important Things to Know, from the Perspective of a Former Investigator (Part 3)

By Tamil Arasu Jul 05, 2022 ANDAs Compliance Drugs Enforcement Inspections NDA

In our previous installment on inspectional preparation and conduct, we covered recommended actions to be inspection ready, how to interact with FDA, and how personnel should conduct themselves during an FDA inspection. In today’s installment, we will cover what happens after the inspection, focusing on responding to an FDA 483 and inspectional outcome decision making. […]

Jul

How to Prepare for an FDA Inspection – Important Things to Know from the Perspective of a Former Investigator (Part 2)

By Tamil Arasu Jul 01, 2022 ANDAs Compliance Drugs FDA Inspections NDA New Drugs Pharmaceutical industry Regulatory Affairs

In our previous installment, Tamil Arasu, former investigator with FDA, detailed preparations that a firm can make in advance of an FDA inspection, as well as details on the types of inspections that FDA performs on drug firms. In today’s post, Tamil will describe appropriate conduct during an inspection, including both the personnel that will […]

Jun

How to Prepare for an FDA Inspection – Important Things to Know from the Perspective of a Former Investigator (Part 1)

By Tamil Arasu Jun 30, 2022 ANDAs Applications Compliance Enforcement FDA Inspections Pharmaceutical industry

When an FDA investigator walks into your facility and informs you that they are going to conduct an inspection, a tense moment may arise even at the most cGMP (Current Good Manufacturing Practices) compliant facility. Paging the employees to inform them of the presence of FDA at the facility is a common occurrence so that […]

1 2 3 Next

Inspections

Join Lachman Consultants (Ireland) at the PDA Ireland Event: Contract Manufacturing – Achieving & Maintaining a Successful Partnership, Cork, 29th Feb.

A New Approach to cGMP Inspections is Coming Soon. Our Contract Pharma Article Gives You a Preview.

Is your company suitably staffed? Our article in Contract Pharma takes this issue head on.

5 Reasons Why You Should Perform a Mock Inspection Now

Is Your Company “Inspection Ready?” Our article in Contract Pharma will help you be better prepared.

Ready for an FDA Inspection? Be prepared. Read our Contract Pharma article.

FDA 2023 Inspection Roadmap, Is “Readiness” in Your Annual Objectives?

How to Prepare for an FDA Inspection – Important Things to Know, from the Perspective of a Former Investigator (Part 3)

How to Prepare for an FDA Inspection – Important Things to Know from the Perspective of a Former Investigator (Part 2)

How to Prepare for an FDA Inspection – Important Things to Know from the Perspective of a Former Investigator (Part 1)

Subscribe to our blog

Recent Articles

Contact Us: