FDA WARNING_LETTER - Cederroth Industrial Products AB - September 02, 2010

On January 20, 2011, the FDA issued a Warning Letter to Cederroth Industrial Products AB following an inspection from August 30 to September 2, 2010, at their Upplands Vasby, Sweden facility. The inspection revealed that the Cederroth breathing mask and 4-in-1 Bloodstopper are medical devices.

The Cederroth breathing mask was found to be adulterated because the firm lacked an approved premarket approval (PMA) application or an investigational device exemption (IDE). It was also misbranded for failure to submit a 510(k) premarket notification.

All of Cederroth's devices were deemed misbranded because the firm failed to fulfill annual establishment registration and device listing requirements, as mandated by section 510 of the Act.

Additionally, the inspection identified Current Good Manufacturing Practice (CGMP) violations of the Quality System (QS) regulation (21 CFR Part 820): 1. Failure to establish and maintain adequate procedures for supplier quality requirements (21 CFR 820.50(a)), specifically regarding the validation of a process used by a supplier for the Cederroth 4-in-1 Bloodstopper. The firm's response to this was deemed adequate. 2. Failure to establish and maintain adequate procedures for incoming product acceptance (21 CFR 820.80(b)),