On July 11 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of:
On July 9-10 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 requested corrective action by a Spanish active pharmaceutical ingredient (API) manufacturing facility, in a warning letter dated June 20 and posted to the FDA website on July 10. In its letter to Encros S.A., FDA said a July 11-15, 2011, inspection of company’s facility in Aranjuez, Spain, identified significant deviations from Current Good Manufacturing Pratices (CGMP) for the manufacture of APIs, including, among other things, a water system incapable of consistently producing purified water and failure to maintain buildings and equipment used in manufacturing. FDA said the company’s August 2011 response lacked sufficient corrective actions, and threatened to bar Encros’ products from entry into the U.S. unless corrective action is taken.
The Food and Drug Administration warned CigarWebService of the Netherlands that violations of the Food Drug & Cosmetic (FD&C Act) by its cigarette tobacco products could result in penalties, no-sale orders, criminal prosecution, seizure, and/or injunction, it said in a warning letter dated June 25 and posted to its website July 10. Among other things, the FDA said a product for sale on CigarWebService’s websites called “Brookfield (mild American blend)” violates the FD&C Act because its description as “mild” makes it a modified risk product, which cannot be sold in the U.S. without FDA approval. The FDA also singled out CigarWebService’s Pink Elephant Vanilla Flavor cigarettes, which contain flavoring in violation of the FD&C Act.
The Food and Drug Administration said Serbian drug manufacturer Hemofarm A.D. will remain on Import Alert, with its products subject to refusal of admission to the U.S., in a warning letter dated June 20 and posted to the FDA website July 10. The FDA’s warning letter was in response to Hemofarm’s December 2011 response to an FDA inspection, which found, among other things: (i) insufficient standards, plans and test procedures to ensure quality and purity (for example, agar plates for recovery of microbial contamination were dry); inadequate processing techniques during water runs; etc. Hemofarm’s response lacked sufficient corrective actions, FDA said. Furthermore, Hemofarm had already failed another inspection in 2007. Therefore, FDA said, Hemofarm’s products will continue to be under Import Alert and barred from entry into the U.S.
During the week of July 2-8, 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 of:
The Food and Drug Administration (FDA) issued the July Interstate Certified Shellfish Shippers List (ICSSL). The ICSSL is published monthly for the information and use by food control officers, the seafood industry and other interested persons. The shippers listed have been certified by regulatory authorities in the United States, Canada, Chile, Korea, Mexico and New Zealand under the uniform sanitation requirements of the National Shellfish Program.
On July 6 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of:
On July 5 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 proposed rule to require unique device identifiers (UDIs) on the labels of medical devices and device packages, with certain exceptions. The proposed rule, which would implement requirements added to the Federal Food, Drug, and Cosmetic Act by Section 226 of the Food and Drug Administration Amendments Act of 2007, is scheduled to be published in the July 10 Federal Register. Comments on the FDA’s proposed rule are due by about Nov. 7. Comments on new information collection requirements contained in the proposed rule are due by Sept. 10.