Devices

Multiple QS Issues in Techlem Inspection

A 6/19-6/22/2023 FDA inspection at Techlem Medical Corporation in Mississauga, Ontario, Canada, found multiple Quality System Regulation violations in the firm’s manufacturing of wheeled stretchers. A just-released 12/26/2023 Warning Letter says the specific violations were:

failure to adequately establish procedures for implementing corrective and preventive action;
failure to adequately establish procedures for quality audits;
failure to establish and maintain a device history file for each type of device;
failure to adequately document acceptance activities to include the signature of the individual conducting the acceptance activities;
failure to adequately establish and maintain procedures to ensure that device history records for each batch, lot, or unit are maintained to demonstrate that the device is manufactured following the device master record; and
failure to adequately establish procedures to control document changes.

The letter says the firm’s responses to each of the inspection observations were inadequate. It also notes that Techlem’s stretchers are misbranded because they did not contain unique device identifiers.

The firm was told to respond with a list of specific steps it has taken to address the violations and prevent their recurrence, with documentation of each step and a schedule for completing the corrections.

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome