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Snapshot 2015 warning letters .pdf

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Title: https://www.pharmamedtechbi.com/publications/the-gray-sheet/42/
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Related Articles: 1
This copy is for your personal, non-commercial use. For high-quality copies or
electronic reprints for distribution to colleagues or customers, click here or call
+1 (908) 547-2200.

Compilation: 2015 Medical
Device Warning Letters
“The Gray Sheet” Jan. 21, 2016

Printed by Mr. Norm Rabin, Maetrics LLC

Snapshot: 2015 Medical Device Quality
-Related Warning Letters
By Shawn M. Schmitt / Email the Author / View Full Issue
Top Stories / Word Count: 743 / Article # 01160118002 / Posted: January 21
2016 11:10 AM

Executive Summary
A "Gray Sheet" analysis has discovered that the industry racked up its fewest
number of FDA quality-related warning letters in nearly a decade. The agency
issued 74 letters that included at least one quality system violation in
calendar year 2015. Other findings: letters to foreign firms is down; CAPA is
the most-oft cited violation; and close-out letters hit a new peak. And check
out our infographic, which includes a listing of where non-US letters went last
year and a breakdown of other data.

Topics Covered in
this Article
Click a keyword for related
General Topics
quality assurance
warning letter
Post-Market Regulation
Pre-Market Regulation
Medical Devices

The medical device industry racked up its fewest number of FDA warning letters in
nearly a decade last year, a "Gray Sheet" analysis finds.
The agency issued 74 warning letters that included at least one quality system
violation in calendar year 2015. Sixty were sent to US firms; 14 to foreign ones.
(See "Compilation: 2015 Medical Device Warning Letters" — "The Gray Sheet,"
Jan. 21, 2016.)
Last year’s count is 21 fewer than in 2014, when 95 quality system letters were sent
out – a 21% decrease. 2015's 74 letters is also a whopping 56% drop from 2012,
when an all-time high of 169 missives were recorded.
“The Gray Sheet” counts as a quality citation any alleged violation of the Quality
System Regulation
, the Medical Device Reporting
(MDR) regulation (21
CFR, Part 803) or the Corrections and Removals
regulation (21 CFR, Part 806).
(Story continues after infographic, below.)

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The bulk of last year’s warning letters were the result of an estimated 521 foreign
and 1,594 domestic good manufacturing practice (GMP) inspections conducted in
fiscal year 2015, according to FDA’s 2016 budget request.
That is in line with the 518 non-US and 1,614 domestic inspections performed in FY
The agency intends to inspect the same number of firms in FY 2016 as it did in FY
'15. An FDA fiscal year runs from Oct. 1 through Sept. 30.
Meanwhile, the "Gray Sheet" analysis discovered that the agency is gaining ground
when it comes to issuing warning letters more quickly.
A majority (56%) of the 74 quality-related letters issued in 2015 was mailed to
manufacturers within four months of the close of an agency inspection. That's up
from 2014, when exactly half were mailed in four months or less.

CAPA Cited Most Often
Premarket Citations
Deviations from corrective and preventive
action requirements – QSR Sec. 820.100
– were the No. 1 deficiency area
cited in warning letters last year.
CAPA deficiencies were noted in 74% of
warning letters released in 2015. That
CAPA was the most-violated subsection
is no surprise, given that the subsection
is always reviewed during an abbreviated
Level 1 FDA inspection.

Overall, there were 91 devicerelated warning letters
sent to
device manufacturers in CY 2015.
While 74 of the missives included a
mix of quality- and premarketrelated violations, the remainder
(17) pertained solely to premarket

Such an audit allows investigators to examine CAPA plus one other subsystem,
including production and process controls, or design controls.
Complaint handling came in second place in 2015. QSR Sec. 820.198
“Complaint Files,” appeared in 47% of last year’s missives.


Where Foreign Letters Went
Only 19% of the 74 quality-related warning letters distributed in CY 2015 were sent
to foreign companies, "The Gray Sheet” discovered.
That is a dramatic drop from 2013 when more than half of letters that year – 51% –
went to non-US firms.
Device-makers in 11 foreign countries were sent letters. UK manufacturers received
the most with four. The UK is closely followed by Japan (with 3), Canada (2) and
China (2).

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Close-Out Letters Highest Ever
Ninety quality-related close-out letters were sent to companies in 2015, the most
ever issued by the agency in a calendar year.
Under the close-out pilot program, FDA sends a letter to a company and posts it on
the agency’s website when concerns outlined in a warning letter have been
addressed. Such correspondence becomes part of a company’s inspectional
For warning letters linked to quality, the agency typically re-inspects a manufacturer
as a prerequisite to issuing a close-out letter. The FDA center or district office that
sent the original warning letter is responsible for issuing the close-out letter.
The agency has closed out 305 warning letters since 2011. FDA previously said it
aims to send one close-out letter for every three warning letters – a goal it more
than reached in 2015.
FDA urges manufacturers to request close-out letters from the agency, but firms
should keep in mind that the program applies only to warning letters issued after
Sept. 1, 2009.
This copy is for your personal, non-commercial use. For high-quality copies or
electronic reprints for distribution to colleagues or customers, click here or call
+1 (908) 547-2200.
Printed by Mr. Norm Rabin, Maetrics LLC

Copyright (c) 2016 Informa Business Intelligence, Inc., an Informa Company. All rights reserved. No part of this article
may be reproduced in any form or incorporated into any information retrieval system without the written permission of the copyright owner.
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Contact us at (888) 670-8900, +1 (908) 547-2200, or custcare@informa.com.

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