# FDA WARNING_LETTER - Techlem Medical Corporation - June 22, 2023

Source: https://www.keypedia.com/records/warning_letter/techlem-medical-corporation/db47f24b-2d83-42fb-bee9-507d044f02ff

> FDA WARNING_LETTER for Techlem Medical Corporation on June 22, 2023. Product: Devices. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: Techlem Medical Corporation
- Inspection Date: 2023-06-22
- Product Type: Devices
- Office Name: Center for Devices and Radiological Health
- Summary: 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 (

## Related Documents

- [WARNING_LETTER - 2013-02-28](https://www.keypedia.com/records/warning_letter/techlem-medical-corporation/4d22e591-295c-43fc-a084-fab8001e0351)

## Related Officers

- [Acting Director](https://www.keypedia.com/people/courtney-h-lias/5e0a64fa-0140-4de2-9eed-929b12def9e9)

Company: https://www.keypedia.com/companies/techlem-medical-corporation/7f5d026a-9683-4afa-9d48-0a4539c77bb4

Office: https://www.keypedia.com/offices/center-for-devices-and-radiological-health/9d89aff6-e435-4764-87be-f58c01aca7f7