On May 2 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The Food and Drug Administration posted a draft guidance for industry and FDA staff on the agency’s regulation of surveying, leveling, or alignment (SLA) Laser Products. The question and answer document outlines FDA’s proposed approach on the applicability of FDA performance standard regulations to these laser products. It includes design features of surveying, leveling or alignment lasers and a discussion of class limits, and says a laser product manufacturer may not avoid designation of its product as an SLA laser simply by marketing it as a laser for other uses. A concurrently issued Federal Register notice (here) says comments on the draft guidance are due Aug. 4.
On May 1 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 April 30 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 on May 2 released a Food Safety Modernization Act (FSMA) Operational Strategy document intended to guide the agency’s efforts as it looks to bring industry into compliance with new regulations and oversee its new programs. “The agency has to design methods to promote widespread voluntary industry compliance with the new rules, as well as establish preventive public health-focused inspection and sampling programs to oversee compliance,” it said in an emailed announcement. “In addition, the FDA is developing effective enforcement strategies to be deployed when producers, processors, distributors and importers fail to comply on a voluntary basis.”
On April 30 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 warned an Italian canned food exporter that it may refuse entry to its products after finding violations of U.S. Low Acid Canned Food (LACF) and Emergency Permit Control regulations. The agency’s April 18 warning letter says that, unless Pancrazio fixes violations uncovered during an FDA inspection of its Cava dei Terreni facility in Italy, FDA may put the company’s products on import alert subject to detention without physical examination. FDA also said it will have to perform a reinspection to verify compliance once the problems are fixed, and will bill Pancrazio’s U.S. agent for expenses incurred.
On April 29 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 April 21-27, 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:
On April 28 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of: