Dive Brief:

• FDA posted a warning letter Tuesday to medical products maker Talon detailing 11 violations of rules governing quality system procedures observed during a March 11-28 inspection of the company’s operations in Houston.
• Five citations in the agency’s letter, dated Aug. 2, were repeat observations from an agency inspection conducted in 2011.
• FDA said it reviewed the company’s April 24 response, including proposed corrective actions, and determined it was inadequate. A Talon executive did not return a request for comment from MedTech Dive.

Dive Insight:

Talon manufactures software-controlled medication cabinets and a range of medical supply carts with functions ranging from organization of anesthesia products to the transport of blood and life-saving equipment. It also makes products used in radiation therapy.

FDA, in its warning letter to company president Norman Shoenfeld, detailed quality system regulation violations including a lack of evidence that audit principles were followed during internal audits. Risk analysis was not being conducted, and employee job descriptions were not created for current job functions, the agency said.

The company failed to establish procedures for design changes and control of nonconforming products, maintain device history records and document acceptance or rejection of incoming component parts, according to the letter.

Talon has not established product servicing procedures or adequate records of acceptable suppliers, contractors and consultants, FDA said. The agency found executive management failed to review the effectiveness of the quality system at defined intervals and quality audits were not performed at defined intervals. Adequate training procedures weren't established and records of document changes were not maintained.

FDA gave the company 15 days to explain in writing the steps it will take to correct the violations outlined in the letter, its timeline for the corrections and how it plans to prevent such issues from happening again. The consequences for failing to promptly address the violations could include property seizure, injunction or monetary penalties. 

Premarket approval applications for related Class III devices, as well as requests for certificates to foreign governments, will not be granted until the violations have been corrected, FDA said. Further, federal agencies may consider the warning letter when awarding contracts, the letter said.