MANUFACTURER CITED FOR ASSEMBLING DEVICES 'IN A PARKING LOT'

Fisher & Paykel Healthcare violated current good manufacturing practices by not documenting the assembly of its CosyCot radiant infant warmers and related accessories to guarantee that the devices meet product specifications, according to a recent FDA warning letter.

The FDA cited the firm for assembling CosyCot warmers "in a parking lot" where there was no "documentation describing the assembly, installation, measurement and test equipment used, and tests conducted to ensure that the device conforms to its specifications," the letter said.

In addition, Fisher & Paykel was cited for not classifying certain radiant infant warmer and neonatal accessory product malfunctions as complaints, and for failing to forward all necessary information regarding complaint evaluations to the principal manufacturing site, according to the FDA.

The firm ceased assembly operations of the radiant infant warmers Nov. 13, 2006, and will resume following implementation of the quality improvement plan, according to the Feb. 2 letter, posted on the agency's website March 1.

The warning letter can be viewed at www.fda.gov/foi/warning_letters/g6231d.pdf ( http://www.fda.gov/foi/warning_letters/g6231d.pdf ).

( http://www.fdanews.com/ddl/34_12/ )