FDAnews Device Daily Bulletin

FDA Flags Florida Facility for CAPA Procedures, Complaints

Sept. 11, 2017

 A Florida device specification developer lacked adequate CAPA procedures, complaint files and sampling plans, according to the FDA.

The FDA issued a Form 483 to Michael D. Williams’ Davie, Florida, facility following a June inspection. According to investigators, the office’s CAPA procedures lacked requirements for ensuring information on quality problems was properly transmitted to those responsible for ensuring quality.

The office also left key information out of complaint files, including device names, dates complaints were received, and complainant addresses and phone numbers. More than 600 complaints of 1,089 logged between November 2014 and June 2017 did not specify the nature and details of the complaint.

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