CDRH Increases Foreign Quality System Inspections

Regulatory NewsRegulatory News | 05 November 2015 |  By 

Although the number of quality system surveillance inspections only rose slightly between 2013 and 2014 overall, the number of such inspections for foreign manufacturers increased by nearly 30%, according to new data released by the FDA’s Center for Devices and Radiological Health (CDRH).

CDRH said the new numbers show that the agency, which previously upped its inspections of foreign generic drug manufacturers, has been working to increase inspections in foreign countries as “foreign manufacturer inventory has been growing rapidly.”

qualSlides courtesy of CDRH

As far as the breakdown by country, Chinese manufacturers are seeing more than double the number of inspections as companies in any other country.


And even though the number of quality system inspections has increased, the number of warning letters issued by FDA decreased slightly from more than 160 in 2012, to 144 in 2013 to 121 in 2014. More than 60% of those warning letters with quality system citations were issued to foreign companies.

In addition, in 2014, 3,740 FDA Form 483 observations cited 21 CFR 820 (quality system regulation) deficiencies. A little less than half of all domestic quality system surveillance inspections resulted in a Form 483 being issued, while 57% of such inspections at foreign sites resulted in a Form 483.


As far as inspectional observations on the warning letters and 483s, “Production and Process Controls and Corrective and Preventive Actions continue to be the most frequently cited QS [Quality System] subsystems,” FDA said, noting that each manufacturer is required to develop, conduct, control, and monitor production processes to ensure that a device conforms to its specifications.

And when deviations from those device specifications occur as a result of the manufacturing process, the manufacturer is required to establish and maintain process control procedures that describe any process controls necessary to ensure conformance to specifications.

2014 Annual FDA Medical Device Quality System Data


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