The Food and Drug Administration issued its weekly Enforcement Report for March 13 that lists the status of recalls and field corrections for food, drugs, biologics, and devices. The report covers both domestic and foreign firms.
On March 13 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of:
On March 12 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 said it may reject premarket approval applications and refuse to issue certificates to foreign governments for Grantech of Taiwan after finding violations of current good manufacturing practices at the medical device company’s Taipei facility. According to FDA, the company’s first response was inadequate. But two responses by the company went unreviewed because of late submission, FDA said.
The Food and Drug Administration informed two medical device companies of violations of Medical Device Reporting and current good manufacturing practice regulations, in two warning letters dated March 1. According to FDA, inspections at Linet’s Slany, Czech Republic, facility (here) and VE Valley Electronics’ Murnau Am Staffelsee facility (here) revealed the violations. Each firm’s initial response was inadequate, FDA said. Both firms have 15 days from the date of receipt of the each respective letter to respond with corrections.
During the week of March 4-10, 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 will hold a public conference in Cincinnati May 1-3, in conjunction with Xavier University, on medical devices. The conference will include presentations from FDA officials and small group breakout sessions. Topics for discussion include a Center for Devices and Radiological Health outlook; European Union regulations; unique device identification; global product strategy; and FDA inspections. Pre-registration is available until April 9 (here), although early registration ends March 13. Registration will also be available on-site, FDA said.
The Food and Drug Administration said a guidance for industry is now available on scored tablet drug applications and labeling. The document, titled “Tablet Scoring: Nomenclature, Labeling, and Data for Evaluation” (here), discusses guidelines and criteria for applications to support approval of a scored tablet, as well as nomenclature and labeling for approved scored tablets, FDA said.
On March 11 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of:
On March 8 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of: