Warning Letter- Not Conforming to Manufacturing Requirements

Sonesta Medical AB was issued a warning letter from the FDA. Excerpts from a warning letter of interest to software professionals:

“This inspection revealed that these devices are 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 procedures to ensure that all purchased or otherwise received product and services conform to specific requirements, as required by 21 CFR 820.50(a).
2. Failure to establish and maintain procedures for receiving, reviewing, and evaluating complaints by a formally designated unit, as required by 21 CFR 820.198(a).
3. Failure to establish and maintain procedures to ensure that the design requirements relating to a device are appropriate and address the intended use of the device, including the needs of the user and patient, as required by 21 CFR 820.30(c).
4. Failure to establish and maintain procedures for validating the device design under defined operating conditions on initial production units, lots, or batches, or their equivalents, as required by 21 CFR 820.30(g).

For more information, see the link below:

https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/sonesta-medical-ab-667325-09222023

About the author

Allison joined SoftwareCPR in 2022, bringing along over ten years of passion for building teamwork and growth in organizations. This is established in part by the greatest University the South has to offer- Mississippi State.

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