The FDA last month slapped Vention Medical with a warning letter over conditions at a plant in Costa Rica, flagging problems with the medical device company’s procedures there.
The July 1 letter was prompted by an FDA inspection in March of a plant in Barreal de Heredia, Costa Rica, the FDA said.
Vention Medical makes thermotherapy systems, cord blood processing systems, negative-pressure wound therapy equipment and catheters at the plant, according to the watchdog agency.
The FDA inspection found that Vention, the result of a rollup of TDC Medical, Advanced Polymers and The MedTech Group, failed to have a validation system in place for its cleaning & sanitation procedures and failed to institute environmental control procedures, according to the letter.
Vention also failed to adequately document its cleaning & maintenance schedules and its corrective & preventive action processes, the FDA said.
Following the 2011 rollup, Vention Medical grew via acquisition with the buyouts of AnsaMed, RiverTech Medical, and Fast Forward Medical. Vention, which is owned by KRG Capital Partners, raised $2.5 million in an equity offering last year.
