FDA WARNING_LETTER - Alpha Medical Instruments, LLC - January 11, 2013

On June 24, 2013, the FDA issued a Warning Letter to Alpha Medical Instruments, LLC, following an inspection from December 19, 2012, to January 11, 2013. The inspection revealed that the firm, which manufactures angiographic balloon catheters and electrophysiology catheters, was in violation of several regulations.

The electrophysiology catheters commercially distributed to (b)(4) were deemed adulterated because Alpha Medical Instruments lacked an approved premarket approval (PMA) or investigational device exemption (IDE) application. They were also misbranded for failing to submit a 510(k) premarket notification. Furthermore, these catheters were adulterated under section 801(e)(1) of the Act, as they were not approved for marketing in the U.S. and did not meet export requirements.

The inspection also found the electrophysiology catheters misbranded due to false and misleading labeling, stating "Manufactured in the U.S.A. for Alpha Medical Instruments LLC," despite being improperly declared upon entry to the U.S. Additionally, the devices were adulterated because manufacturing, packing, storage, or installation methods and controls did not conform to the Quality System (QS) regulation (21 CFR Part 820).

Specific QS regulation violations included: 1. Failure of management to review the quality system suitability and effectiveness at defined intervals (21 CFR 82