The Food and Drug Administration may refuse imports of drug products manufactured at two RPG Life Sciences facilities in India, the agency said in a May 28 warning letter. An FDA inspection at the company’s facility in Navi Mumbai allegedly found current good manufacturing practice violations for active pharmaceutical ingredients. An inspection of RPG’s facility in Ankleshwar found violations of CGMP for finished pharmaceuticals, FDA said.
On June 10 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 June 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:
On June 7-9 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of:
On June 6 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of:
On June 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 weekly Enforcement Report for June 5 that lists the status of recalls and field corrections for food, drugs, biologics, and devices. The report covers both domestic and foreign firms.
On June 4 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of:
On June 3 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 May 29 - June 3, 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: