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HPLC_Help
Granted, the folks writing these letters probably weren't English majors, but still ... this reads like a rough draft - particularly the paragraphs listing the observations.
H_H
H_H
H_H,
Badly written, yes.
But plenty for you to get your teeth into and you should be able to transfer the nonconformity statements to your corrective action process without too much difficulty.
BTW, you may want to ask for the confidential parts of this letter to be deleted from this public forum.
John
We shouldn't assume that the warning letter was directed to the OP's company.
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HPLC_Help
Thanks, John. It wasn't my company, I was just perusing the Med Device Warning Letters. This one struck me as not well-written, but you are right that the information provided remains useful.
H_H
H_H
Wes Bucey
Prophet of Profit
I'm kind of persnickety about grammar and spelling. This letter didn't strike me as anything other than an example of standard bureaucratese. The apparent disregard of current good manufacturing practices on the part of the letter target struck me as a standard example of what can be found in many small businesses which are relative newcomers to the world of government agency regulations. Heck, it's what drives many corporate OEMs to request registration to an international Quality Standard as a prerequisite to consideration for a place in their supply chain. It usually results from a sole proprietor or small partnership deciding that even hiring a quality professional as a temporary consultant is an unnecessary luxury.
I consult on more than manufacturing quality issues and I see similar disregard in many businesses for using Generally Accepted Accounting Principles (GAAP) in their bookkeeping, purchasing, and sales by hiring folks with zero college courses in bookkeeping as their in-house accountant and trusting to some basic computer accounting program. They are utterly dismayed when they encounter some eager beaver local, state, or federal tax agent wanting to perform an audit.
Of course, by the time a federal agency audit happens, the cost of making things right is many times what the cost of a good quality consultant or CPA consultant would have been at the start of business. The common element I've found with such companies that I have personally encountered is that they NEVER had developed a WRITTEN business plan similar to the SBA guidelines found here: (http://www.sba.gov/writing-business-plan) While the guidelines don't specifically mention hiring professional consultants, they do include this tip
I consult on more than manufacturing quality issues and I see similar disregard in many businesses for using Generally Accepted Accounting Principles (GAAP) in their bookkeeping, purchasing, and sales by hiring folks with zero college courses in bookkeeping as their in-house accountant and trusting to some basic computer accounting program. They are utterly dismayed when they encounter some eager beaver local, state, or federal tax agent wanting to perform an audit.
Of course, by the time a federal agency audit happens, the cost of making things right is many times what the cost of a good quality consultant or CPA consultant would have been at the start of business. The common element I've found with such companies that I have personally encountered is that they NEVER had developed a WRITTEN business plan similar to the SBA guidelines found here: (http://www.sba.gov/writing-business-plan) While the guidelines don't specifically mention hiring professional consultants, they do include this tip
You do not expect a regulatory's warning letter to be with rosy words ... Do you ?
Remember that this is after the issue and unsatisfactory responses to the 483's ...
(May be we close this thread before more longer and unconnected posts appear...)
Remember that this is after the issue and unsatisfactory responses to the 483's ...
(May be we close this thread before more longer and unconnected posts appear...)
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