FDA WARNING_LETTER - Techlem Medical Corporation - February 28, 2013

On February 25-28, 2013, an FDA inspection of Techlem Medical Corporation in Mississauga, Canada, revealed that their hospital stretchers, classified as devices, are adulterated under 21 U.S.C. § 351(h). The manufacturing, packing, storage, or installation methods and controls do not conform to the Quality System regulation (21 CFR Part 820).

Violations include: 1. No procedures for corrective and preventive actions (21 CFR 820.100(a)). 2. No procedures or records for approving vendors/suppliers of components and services for Class II devices (21 CFR 820.50). 3. Failure to establish incoming product acceptance procedures; "Receiving and Shipping Reports" lacked documentation of acceptance activities and quantities, and no sampling plan for incoming inspection (21 CFR 820.80(b)). 4. Failure to validate computer software (e.g., (b)(4) for drawing transfers/changes) used in production/quality systems (21 CFR 820.70(i)). 5. No document control procedures for changes to quality protocols and specification drawings (21 CFR 820.40). 6. Lack of documentation for management review meetings, despite a procedure stating they are (b)(4) (2