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The rate at which FDA issues 483s and warning letters is going up, up, up.

Source: FDA email circular advertising 6th annual FDA Inspections Summit dated 25 Aug 2011.

The agency has already issued 874 letters in fiscal 2011, compared with 673 for all of last year.

FDA’s emphasis on enforcement has led to more, better-educated FDA investigators and more inspections this year.

Both drug- and devicemakers are being held to the highest scrutiny. A review of recent 483s shows investigators ticking off observations — from the simplest to the very complex — like never before:

To a Medical Device Manufacturer, 1/18/2011

“Corrective and preventive actions activities have not been adequately documented. During this inspection, I reviewed 33 complaints … regarding your adjustable hospital bed hand controls … None of the corrective actions dated 2008-2010 contained this documentation.”

To an OTC Contract Drug Manufacturer, 2/15/2011

“Procedures are not followed for the cleaning and maintenance of equipment, including utensils used in the manufacture, processing, packing and holding of a drug product.”

To a Medical Device Manufacturer, 1/27/2011

“Records of complaint investigation do not include required information. Complaint does not include the address of the complainant … does not include the Product Number or Description … does not have the ‘Action/Reply’ section completed …”

To a Drug Manufacturer, 2/11/2011

“Your firm’s QA approved a procedure containing incorrect information on 10/26/2010. Specifically, the procedure references a … System which is no longer in use … (and) incorrectly identified …”

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