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September 22, 2023
22
Sep

Warning Letter- Not Conforming to Manufacturing Requirements

September 22, 2023
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,...
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