The Food and Drug Administration issued a lengthy list of corrections to clerical errors in its Jan. 16 proposed rules on produce safety and preventative controls in human food, respectively. The corrections address typos, incorrect references, and the numbering of sections and tables, among other things. Corrections to the produce safety proposal are available (here), and corrections to the preventative controls in human food proposal are available (here).
On March 15 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 debarred Shu Bei Yuan from importing food for five years, in connection with her conviction for false labeling of honey from China in an attempt to evade antidumping duties. The debarment order is effective March 18.
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:
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.
The Food and Drug Administration posted presentations from its Feb. 28-March 1 meeting on the recently issued proposed rules on produce safety and preventative controls for human food (HARPC) (see 13010805 and 13010429). The presentations were given by FDA officials, and include overviews of the two Food Safety Modernization Act proposed rules, their respective regulatory impacts, and educational and technical assistance related to the proposals.
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.
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: