Devices

Multiple Violations in Physitemp Instruments Inspection

David McFarland

— 2 min read
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A 4/29-6/18/2025 FDA inspection at the Physitemp Instruments facility in Clifton, NJ, found multiple violations in the firm’s manufacturing of clinical electronic thermometers, clinical temperature monitoring probes, and a needle microprobe. A just-released 11/12/2025 Warning Letter said specific Quality System Regulation violations were:

  • failure to adequately ensure that when the results of a process cannot be fully verified by subsequent inspection and test, the process is validated with a high degree of assurance and approved according to established procedures;
  • failure to establish and maintain procedures for finished device acceptance to ensure that each production run, lot, or batch of finished devices meets acceptance criteria;
  • failure to adequately establish and maintain procedures to control product that does not conform to specified requirements;
  • failure to establish and maintain procedures that define the responsibility for review and the authority for the disposition of nonconforming product, setting forth the review and disposition process, and documenting the disposition of nonconforming product; and failure to establish and maintain procedures for rework, to include retesting and reevaluation of the nonconforming product after rework to ensure that the product meets its current approved specifications, with rework and reevaluation activities, including a determination of any adverse effect from the rework upon the product, documented in the device history record;
  • failure to establish and maintain procedures for receiving, reviewing, and evaluating complaints by a formally designated unit; and
  • failure to investigate any complaint involving the possible failure of a device, labeling, or packaging to meet any of its specifications, unless such investigation has already been performed for a similar complaint and another investigation is not necessary.

FDA says the inspection found that many of the company’s devices are adulterated because it does not have an approved PMA or IDE in effect for them. The devices are also misbranded because Physitemp did not notify FDA of its intent to introduce the devices into commercial distribution.

The inspection also found that the company failed to develop, maintain, and implement written medical device reporting procedures, FDA says. Finally, the agency found that all of the company’s devices are misbranded because their labeling does not include a unique device identifier. They are also misbranded in that there was a failure or refusal to provide any material or information required under specific regulations.

Physitemp was told to correct the violations promptly and to respond with a list of specific actions it has taken to address the violations and prevent their recurrence, with documentation of each action, and a schedule for completing the corrections.

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