The Food and Drug Administration (FDA) issued the November 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 U.S., Canada, Chile, Korea, Mexico and New Zealand under the uniform sanitation requirements of the National Shellfish Program.
On Nov. 7 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of:
On Nov. 6 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 threatened Canadian manufacturer International Laboratories (Canada) with refusal of its pharmaceutical products and denial of new applications if the company does not correct violations of the Current Good Manufacturing Practice (CGMP) regulations. The FDA warning letter, dated Oct. 23, also said the firm failed to list net contents in U.S. measurements, and listed ingredients considered by FDA to be inactive as active ingredients. FDA said the company has 15 working days from receipt of the letter to notify it of corrective actions.
The Food and Drug Administration will conduct a reinspection of Indonesian device manufacturer Sugih Instrumendo Abadi’s West Java manufacturing facility after finding violations of Current Good Manufacturing Practice requirements of the quality system regulation, it said in an Oct. 22 warning letter. FDA will also refuse pre-market approval applications for Class III devices from the company related to the violations, it said.
During the week of Oct. 29 - Nov. 4, 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 Nov. 5 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of:
On Nov. 2 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of:
On Nov. 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 Oct. 31 that lists the status of recalls and field corrections for food, drugs, biologics, and devices. The report covers both domestic and foreign firms.