Medical Device Warning Letter Statistics for the first Half of the Fiscal Year 2020

The ECA regularly provides you with analyses of the deficiencies in FDA Warning Letters regarding medical devices. In the comparable period of the years 2017, 2018 and 2019 (1 October - 30 September), we mentioned the noticeably low number of Warning Letters. This trend is also evident for the first half of the fiscal year 2020 (1 October 2019 - 31 March 2020). Learn more about the top 3.


FDA Feedback on Combination Products

There is a draft guideline on combination products describing the ways in which a sponsor can communicate with the FDA during the development of a combination product. What does it say?


Marketing of Medical Devices in the UK after the Transitional Period

The UK Medicines and Healthcare Products Regulatory Agency MHRA has published a guide the marketing of medical devices after the transitional period in the UK.


Eurasian Pharmacopoeia Available

The Eurasian Economic Commission published Volume 1 of the EAEU Pharmacopoeia. This Volume contains 157 general texts and general monographs.


Corona: What measures have Governments taken in the Life Sciences Sector?

Governments have been implementing different emergency measures in the fight against the current pandemic. Now an overview of the various measures in the EMEA region has been published.


Warning Letter: FDA criticises Missing Re-Validation

The FDA has recently issued a Warning Letter to criticize, among other things, the lack of revalidation at a pharmaceutical manufacturer. At first sight, this seems surprising, as it replaces stage 3 of the process validation lifecycle, the Continued Process Verification, the periodic re-validation that was common in the past (exceptions are made in the sterile area). What are the reasons for FDA's request?


Warning Letter about Deficits in Aseptic Manufacturing - Part 1: Cleanroom Behaviour and Materials in the Aseptic Area

Deficiencies in aseptic production have led to a Warning Letter for the Japanese company Takeda Pharmaceutical Company Limited. Part 1 of the News deals with inadequate cleanroom performance and inadequate controls of materials used in aseptic production.  What were the reasons for this Warning Letter?


Inspection Observations on Supplier Qualification because of Inspection at Supplier

A US company received an FDA Warning Letter because of problems at their CMO that were not detected in time.


New USP Draft Chapter on Plastic Components Used in Manufacturing

In the current Pharmacopeial Forum revised drafts of the two previously published USP Chapters <665> and <1665> on plastic materials used in pharmaceutical manufacturing have been published for comment.


Brexit: How to import Medicines into UK

The UK Medicines and Healthcare Products Regulatory Agency (MHRA) has just published a Guidance for Wholesaling and Importing Activities after the end of the Transition Period.


FDA Warning Letters: Structure and the "Lessons Learnt" Effect

The unpopular deficiency letters of the FDA contain numerous standard formulations and follow a fixed scheme in their structure. Read more here about the structure of the Warning Letters and why their reading can be very useful in preparing for an FDA inspection. 


Microbiological Environmental Monitoring at the Focus of an FDA Warning Letter

Deficiencies in microbiological environmental monitoring have led to a Warning Letter for the Korean company Samchundang Pharm Co. What deficiencies were found at the inspected company and what measures were required to remedy them?


Swissmedic resumes Inspections

Swissmedic has announced that inspections will again be carried out on site, provided that appropriate protective measures are observed.


USP publishes draft of new chapter <1220> Analytical Procedure Life Cycle

The USP published the long awaited draft of the new chapter on the Lifecycle of Analytical Methods in the Pharmacopoeal Forum.


WHO Publishes Another Draft Guideline on Health-Based Exposure Limits

In June you could already read about a WHO draft guideline on the topic of limit values in cleaning validation. This draft has now been significantly revised and re-issued with a new title "Point to consider when including Health-Based Exposure Limits (HBELs) in cleaning validation". What changes have been made?


Survey Results on the Use of Electronic Documentation in Equipment Qualification

Since at least the end of the 80s, equipment qualification has been an official expected standard. In the meantime, electronic documentation systems have been widely used. Nevertheless, pharmaceutical companies often still work with paper, especially in the field of equipment qualification. Would it not be possible to use more qualification documents electronically? This is something we wanted to find out from you. 14 questions were asked to give an overview of this topic.


Hormones and Homeopathics on the same Equipment: Warning Letter

A manufacturer of homeopathic drugs and hormone preparations in the USA has received a Warning Letter from the FDA due to several GMP violations. Among other things, highly active drugs were produced on the same equipment as the other products.


EU: Checklist for Brexit Preparation

The European Commission has published a 'Brexit Readiness Checklist' for companies doing business with the UK.


How are FDA Inspections and Applications impacted by COVID-19 Restrictions?

The FDA has published a Q&A document with respect to inspections, pending drug applications, and changes in manufacturing facilities for approved pharmaceutical products.


Questions & Answers: Semi-Automated Visual Inspection

The webinar on semi-automated visual inspection of parenteralia on June 16, 2020 met with great interest. In addition to many basic questions regarding visual inspection, specific questions about semi-automated inspection were asked and answered during the webinar. Here you can find a short selection.


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