The Food and Drug Administration sent warning letters to Canadian and U.K. device manufacturers, citing violations of current good manufacturing practice requirements and Medical Device Reporting regulations. Usine Rotec International of Canada (here) and A C Cossor and Son (Surgical) of the U.K. (here) were warned after their responses to the findings of FDA inspections were deemed inadequate. FDA will not grant premarket approval applications and requests for certificates for foreign governments until the violations are corrected, it said.
On Jan. 22 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of:
Food facilities that wish to renew their registration before the Jan. 31 deadline but have lost their Food Facility Registration PIN number must create a new registration by the deadline, said the Food and Drug Administration in an update to its questions and answers on facility registration. The agency no longer has time to process PIN requests before the Jan. 31 deadline for the 2012 registration renewal period, it said. Facilities creating new registrations because of lost PINs shouldn’t lose the compliance or shipping histories from their previous registrations, as long as the new registration has the same information like facility name and address, FDA said.
On Jan. 18-21 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of:
During the week of Jan. 14-20, the Food and Drug Administration modified the following existing Import Alerts (not otherwise listed on the FDA's new and revised import alerts page) on the detention without physical examination and/or surveillance of:
The Food and Drug Administration issued its weekly Enforcement Report for Jan. 16 that lists the status of recalls and field corrections for food, drugs, biologics, and devices. The report covers both domestic and foreign firms.
On Jan. 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 issued a final rule clarifying application of current good manufacturing practice (CGMP) requirements to combinations comprised of drugs, devices, and/or biological products. Depending on the form of combination, CGMP requirements will: (1) apply to each constituent part separately; or (2) satisfy CGMP or quality system regulation requirements for another constituent part if applied to one constituent part. The final rule is effective July 21.
On Jan. 16 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of:
On Jan. 15 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of: