All - The only flaw with this is that, based on my previous discussions with CDRH folks, they have very few auditors and no budget to hire more (this was a few years ago). Therefore, by their admission, the primary methods of keeping manufacturers and importers honest is
1) trust in the manufacturer's basic honesty 2) complaints from competitors, customers, etc. 3) field incidents Their primary concern was keeping up with the laser light shows, which they said they could not set aside auditing on (and for good reason). As a test of the presumption, has anyone on this list ever had a CDRH auditor in their facility, other than related to a laser light show? Regards, Peter L. Tarver, PE Product Safety Manager Sanmina-SCI Homologation Services peter.tar...@sanmina-sci.com > -----Original Message----- > From: Massey, Doug C. > Sent: Wednesday, March 13, 2002 6:51 AM > > Hi Jeffrey, > I've seen answers to this post regarding > enforcement of the IEC standard, as > well as to the CDRH rules. However, no one has > mentioned FDA audits. > > The FDA does conduct periodic audits at the > manufacturer's location as > reported in the Product Reports and Annual > Reports submitted to them. The > auditor will check record keeping, quality > control, and product design > aspects such as proper labeling. My company has > been producing laser > products for many years, and only one audit has > been conducted, that anyone > can remember. I was the representative during > that audit, and I commend the > auditor on his professionalism and thoroughness. > The auditor was a pleasure > to work with, but he was very thorough. Rather > than a 'let me see what I can > nail you on' attitude, the auditor I dealt with > had a 'let me see if I can > help you improve your compliance process' > attitude. The auditor will call > ahead and let you know the date for the audit - > an appreciated courtesy, but > the date is not negotiable. > > Note that the FDA only has jurisdiction over > manufacturing locations within > the US. That's why it falls largely to customs to > enforce imported goods, I > presume. It is also noteworthy that the FDA has a > very broad scope and > generally has much bigger fish to fry than a > manufacturer of low-power laser > devices - I think that's why the frequency of > audits for manufacturers like > us is so low. You may never have the pleasure. > > For complete information about penalties and > other administrative topics, > check > http://www.fda.gov/cdrh/radhlth/fdcact5c.html , > the Electronic Product > Radiation Control section of the Federal Food, > Drug, and Cosmetic Act. > Section 360pp covers Enforcement and Penalties. > > Hope this helps. > > Doug Massey > Lead Regulatory Engineer > LXE, Inc. ------------------------------------------- This message is from the IEEE EMC Society Product Safety Technical Committee emc-pstc discussion list. Visit our web site at: http://www.ewh.ieee.org/soc/emcs/pstc/ To cancel your subscription, send mail to: majord...@ieee.org with the single line: unsubscribe emc-pstc For help, send mail to the list administrators: Ron Pickard: emc-p...@hypercom.com Dave Heald: davehe...@mediaone.net For policy questions, send mail to: Richard Nute: ri...@ieee.org Jim Bacher: j.bac...@ieee.org All emc-pstc postings are archived and searchable on the web at: http://ieeepstc.mindcruiser.com/ Click on "browse" and then "emc-pstc mailing list"
