Recipient: Brymill CorporationProduct: liquid nitrogen cryosurgical devices Date: 2/18/09 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, the manufacture, packing, storage or installation are not in conformity with...Read More
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John is currently providing telephone and face-to-face meetings to discuss: Cybersecurity, Part 11, 483 Response, design controls expectations for software documentation, and other topics.
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