The Food & Drug Administration sent another warning letter to OST Medical Inc., accusing the Warwick, R.I.-based firm violating requirements for manufacturing medical devices.
The federal watchdog agency first warned OST in July 2004, after inspections earlier that year revealed "serious regulatory problems” involving its Sentinel enteral feeding pumps. Although the company received 510(k) clearance in 2001, according to the first warning letter, the FDA found that "the device you are currently marketing is not the device described in the premarket notification" OST received in 2001.
"When significant changes are made to a cleared device, a new 510(k) is required. You redesigned the original device," according to the 2004 missive. "You should have submitted another premarket notification submission for this change."
After OST provided more information to the FDA, the agency closed out the first warning letter in September 2004, writing that “no new 510(k) is required at this time.”
In the second letter, dated Jan. 27, 2009, the FDA said inspections in November and December last year found several violations of its rules requiring quality management systems for medical device makers. Specifically, the FDA’s inspectors found that OST did not "establish and maintain procedures to ensure that all received product conforms to specified requirements,” received components from a vendor not listed on its roster of approved suppliers, used defective labels from an unapproved supplier, failed to keep adequate device history records, failed to investigate complaints involving the device and to implement a program to deal with such complaints.
OST owner and president Peter Sacchetti declined to comment on the second warning letter.
