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.
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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