Siemens Healthcare - FDA Warning Letter Analysis

[yana prus]

The US Food and Drug Administration’s (FDA) recent Warning Letter, released 6 June, cites Siemens Healthcare Diagnostics (Medical Device) company who is alleged to have violated federal law by marketing unapproved products.

In a 29 May warning letter sent to medical device manufacturer Siemens Healthcare, FDA alleges the company’s ADVIA Centaur iPTH immunoassay products manufactured at its Tarrytown, NY facility are adulterated because of current good manufacturing practice (CGMP) deficiencies present in their manufacture.

The company allegedly did not establish or maintain adequate design procedures to ensure appropriate design requirements. Specifically, one of the changes was assessed before the validation report was completed, and before effect of the device change on performance was documented, but the company's assessment claimed that there was no change in performance requiring a pre-market submission.
Another change for non PDP project (and regulatory assessment) was reviewed. The regulatory assessment was made nine months before validation report was completed. The effect of the device changes on performance was not documented until these reports were completed, but Siemens assessment claimed that there was no change in performance requiring a pre-market submission.

FDA also said Siemens’ Centaur device was misbranded as a result of its failure to make a 510(k) premarket notification to FDA or, alternatively, a premarket approval (PMA) submission.

One of the lessons following this WL is to conduct (and document!) the regulatory assessment in the end of a project (or engineering change) when all the design changes are known, and not only in the beginning of a project.
http://www.fda.gov/ICECI/Enforcement.../ucm306168.htm

[Wes Bucey]

The rule of thumb when dealing with ANY bureaucracy, especially with a regulatory body which can shut down a business, is to follow all the bureaucratic procedures meticulously. Almost by definition, bureaucrats are wont to declare any deviation from the procedure as N/C (regardless if it is essentially a "better way"), often elevating the seriousness of the breach drastically (to signal to "watchers" the bureaucrats are VERY diligent.)

Often, it seems the Regulatory Affairs Officer of an organization spends most of his time resolving some bureaucrat's misunderstanding of an organization process or procedure, rather than just assuring his organization follows the regulatory agency's protocols.

Think of it this way - if bureaucrats do not allow themselves broad interpretations of rules, you can be sure those same bureaucrats will be even less tolerant of a regulated organization straying from the letter of the regulations.

[Ronen E]

In my understanding, Siemens's greatest "sin" was administrative:

Your firm's response to the Form FDA 483 (FDA 483) was received by New York District via email in an unsigned document after the close of business on the fifteenth business day after the FDA 483 was issued. The email did not provide attachments related to your response. However, the email indicated a signed response as well as attachments were available for the FDA by logging onto a Siemens File Exchange. The District did not and does not plan to logon to your firm's File Exchange to obtain responses or other information. In addition, the email indicated a hardcopy response was being sent to the District Office. The District received your hard copy response on January 23, 2012.

I bet their response contained some decent arguments, that FDA might have been willing to accept (at least partially), but they presented this response in a manner that is, at the very least, untimely and unprofessional (some might say even a bit arrogant and disrespectful towards the agency).

I believe that no matter how big the differences of opinion are, when dealing with the FDA, some basic proper conduct must always be practised.

It's always a shame to see companies getting entangled simply for not following very basic instructions, like how and when to submit a response