FDA Warns Italian Device Facility of CGMP Violations
The Food and Drug Administration warned Italian device manufacturer Spes Medica Srl that its Battipaglia, Italy, facility isn’t conforming to current good manufacturing practice requirements. Requests for premarket approvals and government certificates related to the violative devices, electromyography needles, may…
Sign up for a free preview to unlock the rest of this article
If your job depends on informed compliance, you need International Trade Today. Delivered every business day and available any time online, only International Trade Today helps you stay current on the increasingly complex international trade regulatory environment.
be denied unless the violations are corrected, FDA said.