Deymond Diagnostics s.r.o. was issued a warning letter from the FDA. Excerpts from a warning letter of interest to software professionals:
The “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 adequate design control procedures to control the design of the device in order to ensure that specified requirements are met, as required by 21 CFR 820.30(a)
2. Failure to establish and maintain adequate procedures for receiving, reviewing, and evaluating complaints by a formally designated unit, as required by 21 CFR 820.198(a)
For more information, see the link below:
