![Microsoft Word - Document6 FDA warning letter CAPA complaint](https://carl1anderson.wordpress.com/wp-content/uploads/2010/11/resource.jpg?w=125&h=170)
Warning Letters for CAPAs & Complaint Investigations
FDA first opened international offices in 2008 in India and China and now has offices in Europe and Latin America as well. The international offices are predominantly focused on GMPs for food, drugs, and medical devices. FDA has also stepped up its inspections of clinical trials in international locations including Russia and Eastern Europe. However, there has not been the corresponding surge in Warning Letters. At least not yet. Here are charges that FDA made in the international Warning Letters:
![bacteria28 CAPA complaint FDA warning letter](https://carl1anderson.wordpress.com/wp-content/uploads/2010/11/bacteria28.jpg?w=150&h=143)
Failure to Investigate Bacterial Contamination
Storz Medical (Switzerland): Failure to establish and maintain adequate procedures for verifying or validating the corrective and preventive action to ensure that such action is effective and does not adversely affect the finished device, as required by 21 CFR 820.100(a)(4). For example, no protocol, including acceptance criteria, was established for the validation of Change Request (b)(4). Additionally, there was no documentation showing that this change was validated. The change was implemented to fix cracked cooling pumps in the Modulith SLX-F2.
The Warning Letter goes on to say:
![sop international complaint investigation failure FDA](https://carl1anderson.wordpress.com/wp-content/uploads/2010/11/sop.jpg?w=150&h=102)
Failure to Establish Procedures for Complaints
Neoventa Medical AB (Sweden): 1. Failure to establish and maintain adequate procedures for implementing corrective and preventive action that include requirements for verifying or validating the corrective and preventive action to ensure that such action is effective and does not adversely affect the finished device and that all activities required under this section and their results be documented, as required by 21 CFR 820.100(a)(4) and (b).
2. Failure to establish and maintain adequate procedures for receiving, reviewing, and evaluating complaints by a formally designated unit, as required by 21 CFR 820.198(a).
Once again the direct connection between the failure to investigate complaints and the failure of a system of CAPA.
![APIs China US FDA Warning Letters CAPA](https://carl1anderson.wordpress.com/wp-content/uploads/2010/11/apis-china-us.jpg?w=150&h=141)
Chinese API Manufacturer Hit with FDA Warning Letter
Pega Medical (Canada): Failure to establish and maintain the requirements, including quality requirements, that must be met by suppliers, contractors, and consultants, as required by 21 CFR 820.50(a)… For example, Complaint NCR No. (b)(4) reported…”
Read the Warning Letters:
Storz Medical, AG Warning Letter
Yunnan Hande Biotech Warning Letter
FDA International Resident Posts
And What About Clinical Trials?
At a recent FDANews conference FDA representative Ann Meeker-O’Connell, M.S., Division of Scientific Investigations, Office of Compliance CDER/FDA, said,
![clinicalTrials_0_0 FDA warning letter international complaint investigations](https://carl1anderson.wordpress.com/wp-content/uploads/2010/11/clinicaltrials_0_0.jpg?w=150&h=118)
Clinical Trial CAPAs Face Different Challenges
That is a very good question and one that many of us have been wrestling with. However, it is clear that FDA has been taking on the question of the international nature of the drug and device industry, including manufacturing and clinical trials.
============
A new service: Please check out the Services page at the top of the Blog to learn more about GxP Services.
============
Please join GxP Perspectives on LinkedIn at:
GxP Perspectives LinkedIn Group
Read about the Academy of Medical Research Report by Nick Taylor in Outsourcing-Pharma
UPDATE: There is a very interesting Important Notice to IRBs that is on the FDA website. Sort of a Coast IRB redux.
Public Comment Period is Open for New FDA Draft Guidance:
FDA Draft Guidance on Electronic Source Data in Clinical Investigations
<<<<<<<<<<<<<<<<<<<<<<<<<<<<<<<<
Visit the TMF Page at the Top Right of the Blog! I am trying to assemble resources for those of us concerned with the Trial Master File. I welcome any contributions you might have of interesting articles and resource documents.
On FDA’s Website there are Two New Warning Letters from FDA to Clinical Investigators that show the need to effectively respond to a Form FDA 483, Inspectional Observations, with a well thought out CAPA Plan.