Quality First International

Is FDA evidence sufficient and credible to corroborate allegations that Theranos, Inc. violated medical device regulations?

A study on the Theranos, Inc. case written by Haroon Atchia and Susan Fromm investigates allegations promulgated, applying grounded-theory research to evidence available publicly, according to experience and Title 21 Part 820 Code of Federal Regulations. The authors scrutinise observations cited by FDA on Form FDA 483s served on Theranos following two Establishment inspections.

London, 9 May 2016

Haroon Atchia – CEO of the London-based medical device regulatory consultancy Quality First International – and Susan Fromm - Technical Specialist with Quality First International and a specialist on US medical device regulations - have written a paper on the case of Theranos, Inc., an American company headquartered at Palo Alto, California, whose tribulations were promulgated in the domestic, US and international media, including The Wall Street Journal, Financial Times, television and internet. Health regulators had proposed revoking the federal license for Theranos Inc.'s California laboratory as they found Theranos out of compliance with certain federal lab requirements.

The case study raises the questions if evidence available publicly from FDA Establishment inspections is sufficient and credible to corroborate allegations expressed by numerous critics that Theranos, Inc. violated medical device regulations – wilfully or otherwise – and that observations identified by FDA reflected systemic deficiencies.

“The investigation we conducted is an example of how disinformation and incomplete information can easily distort conclusions on compliance with medical device regulations”, says Haroon Atchia.

The authors also investigate allegations promulgated, applying grounded-theory research to evidence available publicly, according to experience and Title 21 Part 820 Code of Federal Regulations. They scrutinise observations cited by FDA on Form FDA 483s served on Theranos following two Establishment inspections.

The case study may be requested from QFI, email marija@qualityfirstint.com.

About Quality First International (QFI)

QFI is a London-based medical devices consulting company specialising in solving its clients’ regulatory, technical and compliance challenges to enable medical devices to enter the global marketplace. QFI provides regulatory advice, quality assurance and clinical trial services, with particular emphasis on the European, US, Japanese, Australian, Canadian, Mexican and Chinese marketplaces. All submissions made by QFI have fulfilled the compliance requirements first time round, consistently. QFI’s clients range from start-up companies to multinational organisations, primarily developing a broad range of cutting edge, minimally invasive and cardiovascular products and implants. QFI also specialises in various remediation and business excellence initiatives including solutions to regulatory enforcement, corporate integrity arrangements and expert witness services.