FDA WARNING_LETTER - Global Medical Holdings LLC - September 06, 2012

On October 12, 2012, the FDA issued a Warning Letter to Global Medical Holdings LLC following an inspection from August 22 to September 6, 2012, at their Adel, Iowa facility, which manufactures respiratory therapy devices. The inspection found the devices adulterated under Section 501(h) of the Federal Food, Drug, and Cosmetic Act, as manufacturing, packing, storage, or installation methods did not conform to the Quality System Regulation (21 CFR Part 820) (cGMP).

Violations included: 1. Failure to review, evaluate, and investigate complaints related to possible device failure (21 CFR 820.198(c)), specifically for Aeroneb Go, 310G Mini CTOX, and 605 VacuMax. The firm's response was inadequate as it did not detail an approach for uninvestigated complaints. 2. Failure to review all complaints to determine investigation necessity (21 CFR 820.198(b)), such as for 501 MaxiCompressor and 5055 SportNeb Express, which exceeded the internal complaint rate goal. The response was inadequate for the same reason as above. 3. Failure to include required information in investigations of reportable complaints (21 CFR 820.198(d)), specifically not investigating a 2