FDA WARNING_LETTER - rainbow ltd, inc. - June 23, 2011

On November 1, 2011, the FDA issued a Warning Letter to Rainbow LTD, Inc. dba PN Medical, following an inspection on June 23, 2011. The inspection revealed that "The Breather" therapeutic spirometer, a device for which PN Medical is a specification developer and repacker, was adulterated and misbranded.

The device was deemed adulterated under 21 U.S.C. § 351(h) because its manufacturing, packing, storage, or installation methods did not conform to Quality System (QS) regulation (21 CFR Part 820). Specific QS violations included: 1. Failure to establish and maintain corrective and preventive action (CAPA) procedures (21 CFR 820.100(a)). 2. Failure to establish and maintain procedures for design changes, with unapproved changes to package inserts and website materials promoting uncleared uses (e.g., dysphagia, dysarthria, smoking cessation) (21 CFR 820.30(i)). 3. Failure to establish and maintain procedures for purchasing controls, including evaluating contract manufacturers and ensuring product/service conformity (21 CFR 820.50). 4. Failure to establish and maintain procedures for acceptance activities and document incoming inspections (21 CFR 820.80(a)). 5. Failure