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Michael Causey

FDA Compliance

FDA Warning Letter Emphasis

CAPA, CAPA, and more CAPA!

Published: Thursday, November 6, 2014 - 15:23

After a flurry of activity, it’s been relatively quiet lately on the FDA warning-letter front, though three device makers did get some bad news in recent weeks.

FDA’s Philadelphia office hit Pittsburgh-based Zoll Manufacturing Corporation, a maker of  Class III medical device life vests, with a number of observations, including failure to document a corrective and preventative action program (CAPA); review, evaluate, and investigate complaints; adequately establish procedures for design validation; and develop, maintain, and implement electronic Medical Device Reports (eMDRs) to the agency.

(The eMDR Final Rule, requiring manufacturers and importers to submit eMDRs, was published Feb. 13, 2014. The requirements of this final rule will take effect Aug. 14, 2015.)

Zoll’s senior management was also singled out in the Sept. 23 warning letter for being unable to provide records of adequate attendance at management review meetings in 2013 and 2014.

Out west, the FDA cited Mission Viejo, California-based Alpha Medical Instruments for CAPA and other violations. Alpha Medical manufactures angiographic balloon catheters.

Digging deeper into Alpha’s alleged CAPA problems, the FDA’s Oct. 7 letter noted that the firm closed an investigation without being able to produce documents proving it had conducted an effectiveness check. Additional product problems emerged after the CAPA was closed out. Alpha’s subsequent response was found wanting by the agency.

Alpha was also dinged for failure to establish procedures for reviewing, receiving, and evaluating compliance by a formerly designated unit, among other issues.

It is worth noting that, although industry sometimes complains that FDA inspectors are inconsistent in terms of focus and expectations, it’s pretty hard to say the FDA isn’t sticking with its emphasis on CAPA issues.

Finally, the FDA identified problems of a different sort at Powers Device Technologies Inc., a Del Ray, Florida-based manufacturer of the Pacifier Activated Lullaby. The firm was charged in a Sept. 25 warning letter with making unapproved product modifications and marketing those supposed new benefits without agency review. It’s been marketing the product as FDA-approved when, in fact, the agency said it has not approved the product as now constituted. The company must respond later this month, in writing, to the FDA to address these and other observations.

First published Oct. 15, 2014, on the AssurXblog.


About The Author

Michael Causey’s picture

Michael Causey

James Michael Causey’s been a journalist since he started his own neighborhood newspaper in the 1970s. In addition to quizzing FDA officials for the past 10+ years, he’s also interviewed political satirist Art Buchwald, FCC Chairman Reed Hundt, SEC Chairwoman Mary Schapiro, and is the past president of the Washington Independent Writers. Causey is the editor and publisher of eDataIntegrityReport.com and is a contributing writer on the AssurXblog.