FDANews
The QMN Weekly Bulletin

Lack of QA Procedures Draws Warning Letter

Oct. 17, 2008

Sgarlato Laboratories filled an order for its Pain Free Pumps even though some of the devices were not tested before being shipped and others had expired before they were distributed, according to an FDA warning letter.

During an inspection of its San Jose, Calif., facility Jan. 8–22, Sgarlato was unable to give the FDA “receiving inspection records” for certain lots, the letter says. It adds that the record for one lot states: “Did not test these pumps, had to fill order.”

Saying the devices were adulterated, the FDA cited Sgarlato for failing to establish and maintain procedures for acceptance of incoming products. The firm’s failure to test several pumps of a certain model represents “a serious deficiency in receiving & acceptance; and indicates your firm introduced untested pumps into interstate distribution,” the letter says.
 
The letter can be accessed at www.fda.gov/foi/warning_letters/s6902c.htm.