News

FDA Warning Letter Statistics on Medical Devices in the Past Fiscal Year 2025

On behalf of the ECA Concept Heidelberg regularly evaluates the deficiencies in FDA Warning Letters regarding medical devices. Since medical devices can be part of a combination product consisting of a medicinal product and a medical device (there are other combination options in the USA), these statistics are also of interest to manufacturers of these products. What do the statistics for 2025 look like?

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Qualification does not replace Validation

In the past, some companies considered qualification to be sufficient and did not carry out prospective process validation. A recent Warning Letter from the FDA highlights the consequences of this approach.

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Documented Evidence - a fundamental Principle at the FDA

Documented evidence is a fundamental principle of the FDA in the GMP environment. A recent Warning Letter illustrates this using the example of a lack of cleaning validation. What does the FDA expect?

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Validation Group Developments May through August 2025

Please see the ECA Validation Group's report on what they were working on and what they accomplished between May and August 2025.

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FDA Warning Letter for both missing Process and Cleaning Validation

The FDA's current process validation guideline has been in force since 2011. The issue of cross-contamination has been mentioned in 21 CFR 211 since 1978, and the FDA Guide to Inspections on Cleaning Validation dates back to 1993. Process and cleaning validation have therefore been established procedures in the pharmaceutical environment for a long time. But what happens if neither process nor cleaning validation is in place during an FDA inspection?

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Ongoing/Continued Process Verification - The Perspective of an European GMP Inspector

The introduction of a process validation life cycle brought a new element into play: ongoing/continued process verification. Although it has been known for at least 10 years, this stage still poses a challenge for the pharmaceutical industry. As part of an ECA course on this topic, Dr Franz Schönfeld, an European GMP inspector, presented his perspective on the matter. What does he expect?

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Statistical Process Control (SPC) in a Restaurant - an universal Application

Statistical process control in restaurants? What does this subject line mean? It refers to a brochure published by Donald J. Wheeler, a world-renowned SPC expert, which describes the universal application of quality techniques and statistical process control in restaurants in a very interesting way. How was this done?

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Revalidation - the FDA Perspective

With the FDA Process Validation Guidance for Industry coming into effect, stage 3 in the process validation life cycle ('Continued Process Verification') replaced regular revalidation in the non-sterile area. However, revalidations may of course be conducted on an ad hoc basis. A recent Warning Letter provides some guidance on what the FDA expects in such cases.

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Survey Results: The Use of DoE in the Pharmaceutical Industry - Part I

Design of Experiments (DoE) is mentioned as a method in various ICH guidelines and in a chapter on the European Pharmacopoeia. Is DoE already being used in the pharmaceutical industry and in the manufacture of active pharmaceutical ingredients? The ECA wanted to evaluate this by means of a survey. Read the results in Part I on the outcome of the survey.

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Media Fill and Smoke Studies: FDA's Perspective

In a previous News we reported on deficiencies in media fills. The topic is a priority for the FDA! In a recent Warning Letter, media fills were criticised again, as well as deficiencies in smoke studies. What did the FDA criticise?

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