FDA CDRH Enforcement: Agency Eases Up a Bit at Home, Looks Overseas
Quality system surveillance inspections dropped about 3% in 2013, the FDA’s Center for Devices and Radiological Health (CDRH) says in its latest stats. It’s not sure why, exactly, but posits it’s due to an increase in inspections overseas. That drains away resources for domestic doings.
It’s worth noting that the overall number of inspectional observations dropped by 17 percent in FDA’s latest stats from 2013. FDA’s most frequent inspectional observations remained consistent, with Corrective and preventive action procedures (CAPA) leading the way, followed by complaint reviewing, receiving and evaluating. The trio was rounded out by problems with quality audits to assure quality systems are in compliance. Not much new there. Still, it’s important to know.
For the first time since 2009, the number of warning letters issued by CDRH dropped according to the agency’s most recent annual stats. Fewer than 5% of domestic firms and over 15% of foreign firms inspected received warning letters. That might sound good to US-based device makers, but as manufacturing moves more and more overseas, those higher stats are becoming their problem, too.
Until we receive more recent numbers, we’ll have to look for anecdotal evidence suggesting any deviation in the FDA’s regulatory focus in 2014 or 2015. So far, it’s looking like business as usual.
Let’s take a quick look at some recent warning letters to better illustrate the point:
While FDA’s overseas inspections have tended to focus on India and China, CDRH hit Spanish-based DIMA, a manufacturer of slings and incontinence mesh products, with a warning letter for insufficient environmental controls and other good manufacturing practice (GMP) shortcomings. CDRH hit the form for not having change handling procedures that were up to the mark, and failure to demonstrate that a CAPA it opened ultimately did not require corrective actions.
Back in Tonawanda NY, CDRH’s January 23 warning letter to Praxair criticized the firm for not having clear definitions for what qualified as a reportable event. Further, the agency said the company did not require verification of validation of CAPAs. Praxair makes gas flow products that regulate oxygen flow.