Magnolia Medical Technologies, Inc.

Warning LetterClosed

Gregory J. Bullington CEO Magnolia Medical Technologies, Inc. 200 W. Mercer Street, Suite 500 Seattle , WA 98119 United States Greg.bullington@magnolia-medical.comFEI 3009976527Issued Sep 17, 2021Office of Medical Devices and Radiological Health, Division 3

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Source: FDA, published letter. FDA published this warning letter; View Letter opens FDA's copy. To check it, open FDA's record for this establishment, listed under FEI 3009976527.

Letter Details

Firm: Magnolia Medical Technologies, Inc.
Location: Gregory J. Bullington CEO Magnolia Medical Technologies, Inc. 200 W. Mercer Street, Suite 500 Seattle , WA 98119 United States Greg.bullington@magnolia-medical.com
FEI Number: 3009976527
Country: United States
Issue Date: September 17, 2021
Issuing Office: Office of Medical Devices and Radiological Health, Division 3
Product Type: Medical Devices
Status: Closed
Closeout Letter: May 18, 2022

Summary

Magnolia Medical Technologies received a warning letter for adulteration of the Steripath Gen 2 Blood Collection System, a medical device used in blood collection and diagnostics. FDA inspectors found that the company failed to comply with Current Good Manufacturing Practice (CGMP) requirements under 21 CFR Part 820, specifically identifying failures to establish and maintain adequate procedures for corrective and preventive action (CAPA) as required by 21 CFR 820.100(a). The inspection, conducted from June through July 2021, determined that the device's manufacturing, packing, storage, and installation methods did not meet quality system regulation standards. The company had submitted a response to the initial FDA 483 observations on August 5, 2021, but the violations were not deemed adequately addressed.

Magnolia Medical Technologies, Inc. FDA Warning Letter, September 17, 2021