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366 views3 pages

Rework Procedure For Your Medical Device - GMP Trends

Uploaded by

ravi.you
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as PDF, TXT or read online on Scribd
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10/11/22, 4:10 PM Rework Procedure for Your Medical Device - GMP Trends

Have you established a rework procedure for


your medical device?
Home
/ GMP News

August 15

A rework procedure consists of the corrective actions when a product has


Report Search
failed to meet the specifications, and it’s an integral part of any medical
device production. Search reports…

The Code of Federal Regulations (CFR) Search


defines rework as an action taken on a
nonconforming product so that it will
fulfill the specified DMR requirements
before it is released for distribution. (21
CFR 820.3(x))
Stay in Compliance!
A company recently received the To get the most out of GMP
following observation: Trends®, sign up to one of our
subscription packages for
….. Procedures for rework of nonconforming product have not been valuable, up-to-date
established. information you won't find
anywhere else!
Specifically,

a.         … devices were reworked over the last 3 years; however, the firm’s LEARN MORE
President stated there are no written procedures documenting required
steps for the rework of returned devices. For example:

i.          The … component was replaced by … on the … after receiving a


complaint from the customer that ….
About GMP Trends
ii.         Threaded inserts were cleaned and screws were reinstalled on the GMP TRENDS is a publication for the
rear panel … after receiving a complaint from the customer. pharmaceutical and medical device
industries, trending observations
b.         Specifically, the … components used to manufacture … were
made by FDA investigators during
reworked in-house; however, the firm’s President stated there are no
GMP inspections throughout the
written procedures describing required steps for the rework of
world.
nonconforming raw materials.

According to CFR section 21 CFR 820.90(b)(2): Each manufacturer shall


establish and maintain a rework procedure, to include retesting and
reevaluation of the nonconforming product after rework, to ensure that the
product meets its current approved specifications. Rework and reevaluation
activities, including a determination of any adverse effect from the rework
upon the product, shall be documented in the DHR.

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10/11/22, 4:10 PM Rework Procedure for Your Medical Device - GMP Trends

For additional information pertaining to reworks, see FDA Guidance


Document: Guide to Inspections of Medical Device Manufacturers,
December 1997.

To view more observations pertaining to rework, refer to the following GMP


Trends® Issues: 1094, 1086, 1074 and 1069. 

Stay in Compliance!  Subscribe to GMP Trends® today.

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of the FDA
To get the most out of GMP Trends®, sign up to one of our subscription packages for valuable, up-
to-date information you won't find anywhere else! Every subscription provides the most frequently
cited FDA 483 observations taken from recent FDA Inspections. The non-essential information is
redacted to streamline the facts in an easily readable format. Join the thousands of professionals
who rely on GMP Trends® to keep them informed of the latest FDA Enforcement Trends!

SUBSCRIBE NOW

GMP Trends® was founded because, as quality professionals, we recognized the need for an unbiased editing of all relevant FDA 483's.

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