FDA WARNING_LETTER - Techlem Medical Corporation - June 22, 2023

The FDA issued a Warning Letter to Dr. Sinha, President of a firm in Mississauga, Canada, following an inspection from June 19-22, 2023. The firm manufactures wheeled stretchers, classified as medical devices. The inspection revealed these devices are adulterated under 21 U.S.C. § 351(h) due to non-conformity with Quality System (QS) regulation (21 CFR Part 820).

Key violations include: 1. Failure to adequately establish CAPA procedures (21 CFR 820.100(a)), with the submitted procedure being deficient. 2. Failure to adequately establish quality audit procedures (21 CFR 820.22), lacking documented procedures and evidence of implementation. 3. Failure to establish and maintain a design history file (21 CFR 820.30(j)), with the Quality Manual and Design Control Procedure lacking this requirement or evidence of implementation. 4. Failure to adequately document acceptance activities with signatures (21 CFR 820.80(e)), as 16 final inspection sheets lacked signatures. 5. Failure to adequately establish and maintain device history records (21 CFR 820.184), specifically regarding labeling, with no evidence of implementation for the new procedure. 6. Failure to adequately establish and maintain supplier requirements (