WARNING LETTER
Criticare Technologies, Inc was issued a warning letter from the FDA. Excerpts from a warning letter of interest to software professionals:
CMS# 686915
Criticare Technologies, Inc.
6901 TPC Drive, Suite 300Orlando, FL 32822United States
July 12, 2024
Inspection Dates: March 21, 2024, through May 10, 2024
Inspection Issue(s):
These violations include, but are not limited to, the following:
- Your firm has not adequately performed a design verification for your nGenuity device to confirm that the design output meets design input requirements, as required by 21 CFR 820.30(f). Specifically, the SpO2 accuracy specifications, in a document dated 2006, are defined as (b)(4) for the range of (b)(4) and (b)(4) for the range of (b)(4). Two Pulse (b)(4) Reports from 2000 and 2001 were provided during the inspection to support the above accuracy claims. However, these reports do not support the claims made for the (b)(4). For example, the reports did not include acceptance criteria, a rationale for the sample size of (b)(4) participants, and traceability for the devices reviewed. Your firm has been relying on older design documents for your nGenuity device yet have not performed a sufficient design review to confirm the current design has been verified.
- Your firm has not adequately conducted design validation for your nGenuity devices as required by 21 CFR 820.30(g). Specifically, the 8100E Series (b)(4) provided during the inspection did not include acceptance criteria and did not document a rationale for the sample size of (b)(4) collecting (b)(4) on (b)(4) participants. Your firm has been relying on older design documents for your nGenuity device yet have not performed a sufficient design review to confirm the current device design has been validated.
Finally, you should know that this letter is not intended to be an all-inclusive list of the violations at your firm’s facility. It is your firm’s responsibility to ensure compliance with applicable laws and regulations administered by FDA. The specific violations noted in this letter and in the Inspectional Observations, FDA 483, issued at the close of the inspection may be symptomatic of serious problems in your firm’s manufacturing and quality management systems. Your firm should investigate and determine the causes of any violations and take prompt actions to address any violations and bring the products into compliance.
