MELBOURNE, Australia (Sept. 16) — The U.S. Food & Drug Administration has placed Ansell Ltd.´s Surat Thani, Thailand, plant under "Level 2" detention, meaning all shipments from that facility will have to undergo testing until at least 10 successive shipments pass inspection.
The FDA ordered the detention after two lots randomly selected for inspection failed to meet the agency's defined standards, Melbourne-based Ansell said. All medical devices imported into the U.S. are subject to lot testing by the FDA, Ansell said, and condoms are rated a Class II medical device.
Ansell said it is expediting shipments to the U.S from this facility so that product can be submitted to the FDA for testing and approval. Ansell maintains inventories in the U.S. and also has two other plants supplying this market.
Ansell said it made about 140 condom shipments — accounting for more than 2,000 lots — to the U.S. during its fiscal 2005 without any problems. The two lots that did not meet the standards were tested within the last seven weeks.
Should future shipments during the testing or probationary period not meet standard, this could result in escalation to a Level 3 detention, which would require the plant to be recertified, necessitating alternative supplies to the U.S.