Warning Letter – Lacks Verification Testing

September 17, 2021

CMS 617922

Excerpts from a warning letter of interest to software professionals:

“The United States Food and Drug Administration (FDA) conducted an inspection of your medical device operations at 200 W. Mercer Street, Suite 500, Seattle, WA 98119 from June 3, 2021 through July 15, 2021. During the inspection, an FDA Investigator determined that your firm is a specification developer for the Steripath Gen 2 Blood Collection System (K192247)…

This inspection revealed that the Steripath Gen 2 device is adulterated within the meaning of section 501(h) of the Act, 21 U.S.C. § 351(h), in that the methods used in, or the facilities or controls used for, their manufacture, packing, storage, or installation are not in conformity with the current good manufacturing practice requirements of the Quality System regulation found at Title 21, Code of Federal Regulations (CFR), Part 820…

These violations include, but are not limited to, the following:

1. Failure to establish and maintain adequate procedures for implementing corrective and preventive action, as required by 21 CFR 820.100(a).

2. Failure to establish and maintain adequate procedures for verifying the device design to confirm that the design output meets the design input requirements, as required by 21 CFR 820.30(f). Specifically, your firm did not conduct verification testing to support the shelf life of your Steripath Gen 2 with the butterfly needle inlet accessory.”

See the complete warning letter at this link.

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