On Oct. 21 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of:
On Oct. 18 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of:
On Oct. 17 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of:
The Food and Drug Administration will still hold its public meeting on the Foreign Supplier Verification Program and third-party auditor accreditation proposed rules in Long Beach, Calif., Oct. 22 and 23. The agency had to cancel a similar meeting Oct. 10-11 in Miami due to the federal government shutdown (see 13100803). FDA posted an agenda for the Long Beach meeting (here).
On Oct. 16 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of:
On Oct. 15 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of:
On Oct. 11 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of:
On Oct. 10 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of:
The Food and Drug Administration sent warning letters to device companies in Canada, China, and Japan, citing violations of current good manufacturing practice requirements at facilities owned by Batrik Medical (here), Anji Zhengbang Medical (here), and NIDEK (here), respectively. The letters, all sent between Sept. 19 and Sept. 24, gave each company 15 business days to fix the problems found during FDA inspections.
On Oct. 9 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of: